510(k) K941287
- Device
- LIQUID ALT(SGPT) REAGENT SET
- Applicant
- POINTE SCIENTIFIC, INC.
- 510(k) number
- K941287
- Product code
- CKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-03
- Date received
- 1994-03-17
- Regulation
- 862.1030
- Classification name
- Nadh Oxidation/nad Reduction, Alt/sgpt
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM F WALTERS,JR.
- Address
- 1025 John A. Papalas Dr. Lincoln Park MI US 48146 48146
FDA Registration Numbers#
- 3013660430
- 3005094123
- 3006198300
- 8020316
- 1063851
- 3005360469
- 3003795116
- 2030861
- 1181121
- 9680746
- 2050012
- 3005333358
- 3003741796
- 9610529
- 1319436
- 2432235
- 1319809
- 2250051
- 1832216
- 8040374
- 3002809144
- 1000403749
- 2517506
- 2247288
- 3007662974
- 1827821
- 3011989923
- 3004493545
- 2939693
- 3008517993
- 3003593973
- 3016438761
- 2050010
- 3010825766
- 2085064
- 1616487
- 3014325803
- 9610126
- 3018771894
- 1220972
- 1319681
- 3021841051
- 3006716639
- 3000148879
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CKA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| K113382 | ACE ALT REAGENT | Alfa Wassermann | 2012-07-19 |
| K061020 | DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE | Dade Behring, Inc. | 2006-05-10 |
| K020487 | CARESIDE ALT | Careside, Inc. | 2002-06-04 |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1998-02-02 |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | Trace America, Inc. | 1998-01-07 |
| K974003 | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 | Diagnostic Chemicals , Ltd. | 1997-12-05 |
| K971323 | ALT OR SGPT | Carolina Liquid Chemistries Corp. | 1997-04-21 |
| K965134 | ALT/SGPT | Derma Media Lab., Inc. | 1997-02-18 |
| K961123 | ALT INCORPORATING DST | Trace Scientific , Ltd. | 1996-04-25 |
| K952427 | CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE | Beckman Instruments, Inc. | 1995-09-21 |
| K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 |
| K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT | Dade Intl., Inc. | 1995-06-19 |
| K951818 | HICHEM ALT REAGENT KIT | Hi Chem, Inc. | 1995-05-15 |
| K944080 | ALT QVET | Prisma Systems | 1994-11-22 |
Legacy Summary#
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FDA Review#
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