K881380 is an FDA 510(k) clearance for the B. FRAGTEX. This device is classified as a Kit, Anaerobic Identification (Class I — General Controls, product code JSP).
Submitted by American Biomedical Products, Inc. (Tulsa, US). The FDA issued a Cleared decision on October 6, 1988, 188 days after receiving the submission on April 1, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K881380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1988 |
| Decision Date | October 06, 1988 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSP — Kit, Anaerobic Identification |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2660 |