K842151 is an FDA 510(k) clearance for the CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT. This device is classified as a Antisera, Immunoperoxidase, Chlamydia Spp. (Class I - General Controls, product code LKH).
Submitted by Bartels Immunodiagnostic Supplies, Inc. (Walker, US). The FDA issued a Cleared decision on July 20, 1984, 51 days after receiving the submission on May 30, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K842151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1984 |
| Decision Date | July 20, 1984 |
| Days to Decision | 51 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 |