ABBOTT LABORATORIES STREP A EIA
FDA 510(k) clearance K823569 · decided 1983-03-01
Clearance details
- K-number
- K823569
- Device name
- ABBOTT LABORATORIES STREP A EIA
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1982-12-03
- Decision date
- 1983-03-01
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GTZ
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, 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 |
|---|---|---|
| BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (K012521) | Binax, Inc. | 2001-11-30 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |