The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Unicalibrator Kit.
| Device ID | K922021 |
| 510k Number | K922021 |
| Device Name: | UNICALIBRATOR KIT |
| Classification | Plasma, Control, Normal |
| 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 | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-30 |
| Decision Date | 1992-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450006756 | K922021 | 000 |