K930984 is an FDA 510(k) clearance for the ACCESS(R) TOTAL IGE ASSAY. This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on June 9, 1993, 104 days after receiving the submission on February 25, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K930984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1993 |
| Decision Date | June 09, 1993 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DGC — Ige, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |