Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid M
Summary
Co-Innovation Biotech Co., Ltd. received 510(k) clearance for Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50, a LDJ device. Cleared on 2024-01-17.
Details
Source
510(k) Clearance
External ID
K232732
Action Date
2024-01-17
Status
Traditional
Category
device
Product Code
LDJ
Product Description
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50. Product code: LDJ.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Co-Innovation Biotech Co., Ltd. has received 4 total clearances in our database.
Co-Innovation Biotech Co., Ltd. has 4 FDA actions in our database, including 4 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Co-Innovation Biotech Co., Ltd. have FDA actions?
Co-Innovation Biotech Co., Ltd. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232732" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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