The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Asserachrom Protein C Kit.
| Device ID | K854016 |
| 510k Number | K854016 |
| Device Name: | ASSERACHROM PROTEIN C KIT |
| Classification | Conversion To Creatinine, Creatine |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | B Le |
| Correspondent | B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | JLA |
| CFR Regulation Number | 862.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-27 |
| Decision Date | 1986-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450009446 | K854016 | 000 |