K955363 is an FDA 510(k) clearance for the INCSTAR HSZ I/II IGG ELISA ASSAY. This device is classified as a Formalin-saline (Class I - General Controls, product code IGC).
Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on July 24, 1996, 245 days after receiving the submission on November 22, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K955363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1995 |
| Decision Date | July 24, 1996 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | IGC — Formalin-saline |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |