K964294 is an FDA 510(k) clearance for the N-ASSAY TIA APO A1/B MULTI CALIBRATOR. This device is classified as a Alpha-1-lipoprotein, Antigen, Antiserum, Control (Class II - Special Controls, product code DER).
Submitted by Crestat Diagnostics, Inc. (Murrieta, US). The FDA issued a Cleared decision on August 1, 1997, 276 days after receiving the submission on October 29, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5580.
| 510(k) Number | K964294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1996 |
| Decision Date | August 01, 1997 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DER — Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5580 |