The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Neoplastine(r) Ci Kit.
| Device ID | K922565 |
| 510k Number | K922565 |
| Device Name: | NEOPLASTINE(R) CI 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 | 1992-06-01 |
| Decision Date | 1992-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450006667 | K922565 | 000 |
| 03607450006056 | K922565 | 000 |