K901975 is an FDA 510(k) clearance for the IPAZYME(TM) CHLAMYDIA TRUE IGM(TM). 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 8, 1991, 311 days after receiving the submission on May 1, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K901975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1990 |
| Decision Date | March 08, 1991 |
| Days to Decision | 311 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 |