K861631 is an FDA 510(k) clearance for the SLIDE CULTURE U 'EIKEN'. This device is classified as a Kit, Screening, Urine (Class I - General Controls, product code JXA).
Submitted by Syn-Kit, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 10, 1986, 42 days after receiving the submission on April 29, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K861631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1986 |
| Decision Date | June 10, 1986 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JXA — Kit, Screening, Urine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |