K910644 is an FDA 510(k) clearance for the IPAZYME (TM) CHLAMYDIA IGG-IGA. This device is classified as a Antisera, Immunoperoxidase, Chlamydia Spp. (Class I - General Controls, product code LKH).
Submitted by Savyon Diagnostics , Ltd. (Ashdod, IL). The FDA issued a Cleared decision on March 19, 1991, 33 days after receiving the submission on February 14, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K910644 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1991 |
| Decision Date | March 19, 1991 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LKH — Antisera, Immunoperoxidase, Chlamydia Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |