K833738 is an FDA 510(k) clearance for the LEAP STREP TEST KIT. This device is classified as a Exoenzymes, Multiple, Streptococcal (Class I - General Controls, product code GTP).
Submitted by Cooper Biomedical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983, 63 days after receiving the submission on October 25, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K833738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1983 |
| Decision Date | December 27, 1983 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GTP — Exoenzymes, Multiple, Streptococcal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3720 |