TINA-QUANT MICROALBUMIN
FDA 510(k) clearance K932950 · decided 1995-02-10
Clearance details
- K-number
- K932950
- Device name
- TINA-QUANT MICROALBUMIN
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-17
- Decision date
- 1995-02-10
- Days to decision
- 603 days
- Clearance type
- Traditional
- Product code
- JIR
- Device class
- 1
- Regulation number
- 862.1645
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (K022538) | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 |
| URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (K001810) | Flexsite Diagnostics, Inc. | 2000-08-14 |
| IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (K994035) | Diagnostic Chemicals , Ltd. | 2000-02-01 |
| NEW MULTIPLES REAGENT STRIPS (K992257) | Bayer Corp. | 1999-11-24 |
| MICROALBUSTIX REAGENT STRIPS (OTC) (K991315) | Bayer Corp. | 1999-11-12 |
| UALB (K983774) | Abbott Laboratories | 1999-01-28 |
| HEALTH CHECK URI-TEST PROTEIN IN URINE (K972960) | Tcpi, Inc. | 1998-10-07 |
| MICROALBUSTIX REAGENT STRIPS (K982219) | Bayer Corp. | 1998-08-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |