ENZYMUN-TEST{R} AFP
FDA premarket approval P860044/S001 · decided 1990-08-03
Approval details
- PMA number
- P860044
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENZYMUN-TEST{R} AFP
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Boehringer Mannheim Corp.
- Date received
- 1990-06-19
- Decision date
- 1990-08-03
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ELECYS IGE ASSAY (K984326) | Boehringer Mannheim Corp. | 1999-02-08 |
| ACCU-CHEK HQ SYSTEM (K983047) | Boehringer Mannheim Corp. | 1999-02-05 |
| ELECSYS IGE CALCHECK (K984419) | Boehringer Mannheim Corp. | 1999-02-02 |
| MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (K984425) | Boehringer Mannheim Corp. | 1999-01-20 |
| ELECSYS CALCHECK TROPONIN T (K984372) | Boehringer Mannheim Corp. | 1998-12-14 |
| ELECSYS TROPONIN T STAT TEST (K984105) | Boehringer Mannheim Corp. | 1998-12-08 |
| ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503) | Boehringer Mannheim Corp. | 1998-12-01 |
| PRECISET SERUM PROTEINS CALIBRATOR (K983469) | Boehringer Mannheim Corp. | 1998-11-25 |