The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Ptt Automate Test Kit.
| Device ID | K861190 |
| 510k Number | K861190 |
| Device Name: | PTT AUTOMATE TEST KIT |
| Classification | Test, Time, Partial Thromboplastin |
| 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 | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450005957 | K861190 | 000 |