The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Now Streptococcus Pneumoniae Test.
| Device ID | K012521 |
| 510k Number | K012521 |
| Device Name: | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Contact | Pamela Angell |
| Correspondent | Pamela Angell BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877011092 | K012521 | 000 |
| 10811877011061 | K012521 | 000 |