K870231 is an FDA 510(k) clearance for the KULTSURE. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Ncs Diagnostics, Inc. (Mississauga, L4z 1y6, CA). The FDA issued a Cleared decision on February 4, 1987, 14 days after receiving the submission on January 21, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K870231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1987 |
| Decision Date | February 04, 1987 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIO — Device, Specimen Collection |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |