IN VITRO TEST DETERMINATION OF SGPT(ALT)
FDA 510(k) clearance K854186 · decided 1985-12-25
Clearance details
- K-number
- K854186
- Device name
- IN VITRO TEST DETERMINATION OF SGPT(ALT)
- Applicant
- Clinical Data, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-15
- Decision date
- 1985-12-25
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- CKA
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Boston, MA, 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 |
|---|
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST (K120945) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| ACE ALT REAGENT (K113382) | Alfa Wassermann | 2012-07-19 |
| DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE (K061020) | Dade Behring, Inc. | 2006-05-10 |
| CARESIDE ALT (K020487) | Careside, Inc. | 2002-06-04 |
| ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980028) | Trace America, Inc. | 1998-02-02 |
| TRACE REAGENT LINE FOR THE COBAS MIRA (K973869) | Trace America, Inc. | 1998-01-07 |
| ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (K974003) | Diagnostic Chemicals , Ltd. | 1997-12-05 |
| ALT OR SGPT (K971323) | Carolina Liquid Chemistries Corp. | 1997-04-21 |
| ALT/SGPT (K965134) | Derma Media Lab., Inc. | 1997-02-18 |
| ALT INCORPORATING DST (K961123) | Trace Scientific , Ltd. | 1996-04-25 |
| CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE (K952427) | Beckman Instruments, Inc. | 1995-09-21 |
| ALANINE AMINOTRANSFERASE REAGENT SYSTEM (K952744) | Medical Diagnostic Technologies, Inc. | 1995-08-07 |
Recalls involving this device
No recalls on record reference this clearance.