The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni.
| Device ID | K991726 |
| 510k Number | K991726 |
| Device Name: | BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Contact | Pamela S Angell |
| Correspondent | Pamela S 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 | 1999-05-20 |
| Decision Date | 1999-08-27 |
| Summary: | summary |