BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
FDA 510(k) clearance K012521 · decided 2001-11-30
Clearance details
- K-number
- K012521
- Device name
- BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
- Applicant
- Binax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-06
- Decision date
- 2001-11-30
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- GTZ
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Portland, ME, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UNI-GOLD STREP A TEST KIT (K011709) | Trinity Biotech, Plc | 2001-11-08 |
| MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (K010523) | Binax, Inc. | 2001-03-15 |
| BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI (K991726) | Binax, Inc. | 1999-08-27 |
| ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (K971522) | Abbott Laboratories | 1998-03-03 |
| STREP A OIA MAX (K962060) | Biostar, Inc. | 1997-07-23 |
| STREPTOLEX-STAT (K962296) | Unipath , Ltd. | 1996-12-16 |
| OSOM STREP A TEST (K961423) | Wyntek Diagnostics, Inc. | 1996-10-11 |
| EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (K962146) | Excel Scientific, Inc. | 1996-10-07 |
| CARDS Q.S. STREP A (K955108) | Quidel Corp. | 1996-04-15 |
| BINAX STREP A TEST (K960712) | Binax, Inc. | 1996-03-22 |
| ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) (K952819) | Abbott Laboratories | 1996-01-26 |
| QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) (K954257) | Quidel Corp. | 1995-10-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 recall (Z-3184-2024) | Cypress Medical Products LLC | 2024-09-19 |