The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Ptt-lt Test Kit.
| Device ID | K941210 |
| 510k Number | K941210 |
| Device Name: | PTT-LT TEST KIT |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B Le, Ph.d |
| Correspondent | Andrew Loc B Le, Ph.d AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1995-03-21 |