The following data is part of a premarket notification filed by American Dade with the FDA for Coagulation Factor V Deficient Substr.
Device ID | K841364 |
510k Number | K841364 |
Device Name: | COAGULATION FACTOR V DEFICIENT SUBSTR |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | AMERICAN DADE 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-02 |
Decision Date | 1984-04-25 |