K992528 is an FDA 510(k) clearance for the BIOCHECK IGE ELISA, MODEL BC-1035. This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on September 21, 1999, 55 days after receiving the submission on July 28, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K992528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1999 |
| Decision Date | September 21, 1999 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DGC — Ige, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |