TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY
FDA premarket approval P840019/S012 · decided 1996-03-07
Approval details
- PMA number
- P840019
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Hybritech, Inc.
- Date received
- 1995-09-21
- Decision date
- 1996-03-07
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- MODIFICATIONS TO THE HYBRITECH TANDEM-E CEA ASSAY WHITH ENHANCEMENTS IN THE FORMUALTION OF THE ALKALINE PHOSPHATASE-LABELED ANTI-CEA ANTIBODY CONJUGATE AND THE ADDTION OF THE BLOCKING REAGENT POLY MAK 33, A COPOLYMER OF INTACT AND FAB FRAGMENTED MOUSE ANTI-HUMAN CK-MM ANTIBODIES
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (K972666) | Hybritech, Inc. | 1997-09-11 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573) | Hybritech, Inc. | 1996-08-19 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810) | Hybritech, Inc. | 1994-01-11 |
| TANDEM-E IGE II CALIBRATION VERIFICATION SET (K922754) | Hybritech, Inc. | 1993-02-17 |
| HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (K921745) | Hybritech, Inc. | 1992-07-30 |
| TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (K921252) | Hybritech, Inc. | 1992-07-17 |
| TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (K920556) | Hybritech, Inc. | 1992-07-17 |
| TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (K921763) | Hybritech, Inc. | 1992-06-09 |