REFLOTRON(R) ALT (GPT)
FDA 510(k) clearance K864082 · decided 1986-12-04
Clearance details
- K-number
- K864082
- Device name
- REFLOTRON(R) ALT (GPT)
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-20
- Decision date
- 1986-12-04
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- CKD
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (K991834) | Cholestech Corp. | 1999-09-09 |
| ORTHO ALT MICROWELL TEST SYSTEM (K941192) | Ortho Diagnostic Systems, Inc. | 1995-05-16 |
| COBAS READY ALT REAGENT (K896237) | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| VIRGO(R) MICROWELL ALT ASSAY (K884784) | Electro-Nucleonics, Inc. | 1988-12-29 |
| ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (K883387) | Tech-Co, Inc. | 1988-10-13 |
| SGPT (ALT) REAGENT SET (COLORIMETRIC) (K860485) | Sterling Diagnostics, Inc. | 1986-04-03 |
| SGPT REAGENT SET (K844283) | Livonia Diagnostics, Inc. | 1984-11-27 |
| SGPT REAGENT SET (K841059) | Medical Specialties, Inc. | 1984-05-01 |
| SGPT REAGENT SET (K821207) | Omega Medical Electronics | 1982-07-14 |
| SGPT REAGENT SET (K820491) | Anco Medical Reagents & Assoc. | 1982-03-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138. recall (Z-1303-04) | Roche Diagnostics Corp. | 2004-07-31 |
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 |