The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Asserachrom Pf4 Kit.
| Device ID | K862774 |
| 510k Number | K862774 |
| Device Name: | ASSERACHROM PF4 KIT |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Oc B Le |
| Correspondent | Oc B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1986-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450009514 | K862774 | 000 |