510(k) K961431
- Device
- LACTATE DEHYDROGENASE REAGENT SET
- Applicant
- POINTE SCIENTIFIC, INC.
- 510(k) number
- K961431
- Product code
- CFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-03
- Date received
- 1996-04-15
- Regulation
- 862.1440
- Classification name
- Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM F WALTERS
- Address
- 1025 John A. Papalas Dr. Lincoln Park MI US 48146 48146
FDA Registration Numbers#
- 3013660430
- 3005094123
- 3006198300
- 8020316
- 1063851
- 3003795116
- 2030861
- 1181121
- 9680746
- 2050012
- 3003941694
- 3005333358
- 3003741796
- 9610529
- 2432235
- 1319809
- 3012963943
- 2250051
- 1832216
- 8040374
- 3002809144
- 2517506
- 2247288
- 3007662974
- 1827821
- 3011989923
- 3004493545
- 2939693
- 3016438761
- 3003593973
- 3002642396
- 2050010
- 3010825766
- 2085064
- 1616487
- 3014325803
- 9610126
- 1220972
- 1319681
- 3021841051
- 3000308930
- 3006716639
- 3000148879
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CFJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-10-02 |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Alfa Wassermann, Inc. | 2009-09-09 |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Abaxis, Inc. | 2005-07-08 |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | Diagnostic Chemicals , Ltd. | 1998-01-22 |
| K973589 | LIQUID LDH-L REAGENT SET | Pointe Scientific, Inc., | 1997-10-08 |
| K970684 | LACTATE DEHYDROGENASE (LD) | Randox Laboratories, Ltd. | 1997-05-07 |
| K971398 | LD-L REAGENT | Carolina Liquid Chemistries Corp. | 1997-05-02 |
| K964912 | LACTATE DEHYDROGENASE | Derma Media Lab., Inc. | 1997-01-09 |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 |
| K946022 | HICHEM LDH/L REAGENT KIT | Hichem Diagnostics | 1995-02-23 |
| K942964 | LACTATE DEHYDROGENASE QVET | Prisma Systems | 1994-12-29 |
| K935175 | LACTATE DEHYDROGENASE (LD) | Em Diagnostic Systems, Inc. | 1993-12-16 |
| K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Em Diagnostic Systems, Inc. | 1993-02-05 |
| K924965 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-11-16 |
| K923412 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-09-18 |
Legacy Summary#
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FDA Review#
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