The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Liatest(r) At Iii Test Kit.
| Device ID | K905110 |
| 510k Number | K905110 |
| Device Name: | LIATEST(R) AT III TEST KIT |
| Classification | Antithrombin Iii Quantitation |
| 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 | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1991-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450005684 | K905110 | 000 |