The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Sta-liatest D-di Test Kit.
Device ID | K964728 |
510k Number | K964728 |
Device Name: | STA-LIATEST D-DI TEST KIT |
Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
Applicant | AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
Contact | Andrew Loc B. Le |
Correspondent | Andrew Loc B. Le AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
Product Code | DAP |
CFR Regulation Number | 864.7320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-25 |
Decision Date | 1997-06-26 |
Summary: | summary |