Crosstex VH2O2 Chemical Indicators
Summary
Crosstex International, Inc. (A Cantel Medical Company) received 510(k) clearance for Crosstex VH2O2 Chemical Indicators, a JOJ device. Cleared on 2021-07-15.
Details
Source
510(k) Clearance
External ID
K200096
Action Date
2021-07-15
Status
Special
Category
device
Product Code
JOJ
Product Description
Crosstex VH2O2 Chemical Indicators. Product code: JOJ.
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.
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 Crosstex International, Inc. (A Cantel Medical Company) have FDA actions?
This is the only FDA action we have on record for Crosstex International, Inc. (A Cantel Medical Company) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K200096" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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