3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
Summary
3M Company received 510(k) clearance for 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228, a JOJ device. Cleared on 2021-09-05.
Details
Source
510(k) Clearance
External ID
K212081
Action Date
2021-09-05
Status
Special
Category
device
Product Code
JOJ
Product Description
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228. Product code: JOJ.
Company
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. 3M Company has received 15 total clearances in our database.
3M Company has 17 FDA actions in our database, including 2 recalls and 15 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 3M Company have FDA actions?
3M Company has 17 FDA actions in our database, including 2 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212081" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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