ICON STREP B IMMUNOENZYMETRIC ASSAY
FDA 510(k) clearance K911417 · decided 1991-07-24
Clearance details
- K-number
- K911417
- Device name
- ICON STREP B IMMUNOENZYMETRIC ASSAY
- Applicant
- Hybritech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-01
- Decision date
- 1991-07-24
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- GTZ
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (K012521) | Binax, Inc. | 2001-11-30 |
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| 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 |
|---|---|---|
| TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY (P840019/S012) | Hybritech, Inc. | 1996-03-07 |
| STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY (P840019/S010) | Hybritech, Inc. | 1994-03-17 |
| TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY (P840019/S011) | Hybritech, Inc. | 1994-01-13 |
| TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY (P840019/S009) | Hybritech, Inc. | 1990-04-17 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S008) | Hybritech, Inc. | 1989-12-13 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S007) | Hybritech, Inc. | 1989-09-06 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S006) | Hybritech, Inc. | 1987-04-30 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S005) | Hybritech, Inc. | 1986-11-05 |