The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Protime Automate Test Kit.
| Device ID | K864392 |
| 510k Number | K864392 |
| Device Name: | PROTIME AUTOMATE TEST KIT |
| Classification | Test, Time, Prothrombin |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Loc B Le |
| Correspondent | Loc B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-06 |
| Decision Date | 1987-01-05 |