K852869 is an FDA 510(k) clearance for the SELECTICULT-CHLAMYDIA. This device is classified as a Antisera, Immunoperoxidase, Chlamydia Spp. (Class I - General Controls, product code LKH).
Submitted by Scott Laboratories, Inc. (Fiskeville, US). The FDA issued a Cleared decision on September 19, 1985, 73 days after receiving the submission on July 8, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K852869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 1985 |
| Decision Date | September 19, 1985 |
| Days to Decision | 73 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 |