ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
FDA 510(k) clearance K871780 · decided 1987-06-04
Clearance details
- K-number
- K871780
- Device name
- ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT)
- Applicant
- Biochemical Trade, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-06
- Decision date
- 1987-06-04
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- CIT
- Device class
- 2
- Regulation number
- 862.1100
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biochemical Trade
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- (K093883) | Seppim S.A.S. | 2010-09-20 |
| ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (K080485) | Diasys Diagnostics Systems GmbH | 2008-12-04 |
| ACTIVATED ASPARTATE AMINOTRANSFERASE (K071525) | Abbott Laboratories | 2008-03-19 |
| AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (K071580) | Thermofisher Scientific OY | 2007-10-03 |
| COBAS C 111 ANALYZER (K071211) | Roche Diagnostics | 2007-07-30 |
| HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060318) | Horiba Abx | 2006-08-08 |
| WIENER LAB GOT (AST) UV AA LIQUIDA (K023551) | Wiener Laboratories Saic | 2002-12-09 |
| AST (SGOT) (K013698) | Jas Diagnostics, Inc. | 2001-12-21 |
| WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. (K013145) | Wiener Laboratories Saic | 2001-11-27 |
| ATAC PAK AST REAGENT KIT (K010488) | Elan Holdings, Inc. | 2001-04-09 |
| VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 (K001679) | Ortho-Clinical Diagnostics, Inc. | 2000-06-28 |
| WAKO L-TYPE GOT TEST (K993468) | Wako Chemicals USA, Inc. | 1999-12-16 |
Recalls involving this device
No recalls on record reference this clearance.