The following data is part of a premarket notification filed by American Dade with the FDA for Immunoadsorbed Factor V Deficient Plasma (human).
Device ID | K870354 |
510k Number | K870354 |
Device Name: | IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Contact | Karen H Darcy |
Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-29 |
Decision Date | 1987-02-10 |