K842239 is an FDA 510(k) clearance for the VENTRESCREEN STREP A TEST. This device is classified as a Antisera, All Types, Streptococcus Pneumoniae (Class I - General Controls, product code GWC).
Submitted by Ventrex Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on July 2, 1984, 27 days after receiving the submission on June 5, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K842239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1984 |
| Decision Date | July 02, 1984 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GWC — Antisera, All Types, Streptococcus Pneumoniae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |