K012521 is an FDA 510(k) clearance for the BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST. This device is classified as a Antisera, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTZ).
Submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on November 30, 2001, 116 days after receiving the submission on August 6, 2001.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K012521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2001 |
| Decision Date | November 30, 2001 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTZ — Antisera, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |