CFJ — Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Class II
FDA product code CFJ covers "Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase", a Class II medical device regulated under 21 CFR 862.1440. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFJ
- Device Class
- Class II
- Regulation Number
- 862.1440
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131975 | Alfa Wassermann Diagnostic Technologies | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, A | Oct 2, 2013 |
| K091544 | Alfa Wassermann | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Sep 9, 2009 |
| K051108 | Abaxis | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Jul 8, 2005 |
| K974859 | Diagnostic Chemicals | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | Jan 22, 1998 |
| K973589 | Pointe Scientific, Inc | LIQUID LDH-L REAGENT SET | Oct 8, 1997 |
| K970684 | Randox Laboratories | LACTATE DEHYDROGENASE (LD) | May 7, 1997 |
| K971398 | Carolina Liquid Chemistries | LD-L REAGENT | May 2, 1997 |
| K964912 | Derma Media Lab | LACTATE DEHYDROGENASE | Jan 9, 1997 |
| K961431 | Pointe Scientific, Inc | LACTATE DEHYDROGENASE REAGENT SET | Jun 3, 1996 |
| K952747 | Medical Diagnostic Technologies | LACTATE DEHYDROGENASE REAGENT SYSTEM | Aug 7, 1995 |
| K946022 | Hichem Diagnostics | HICHEM LDH/L REAGENT KIT | Feb 23, 1995 |
| K942964 | Prisma Systems | LACTATE DEHYDROGENASE QVET | Dec 29, 1994 |
| K935175 | Em Diagnostic Systems | LACTATE DEHYDROGENASE (LD) | Dec 16, 1993 |
| K924703 | Em Diagnostic Systems | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Feb 5, 1993 |
| K924965 | Olympus | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Nov 16, 1992 |
| K923412 | Olympus | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Sep 18, 1992 |
| K921025 | Synermed | SYNERMED LDHH-L REAGENT KIT | Mar 23, 1992 |
| K915803 | Data Medical Associates | DMA LD KINETIC PROCEDURE | Mar 18, 1992 |
| K914262 | Em Diagnostic Systems | ABBOTT QUICKSTART LDH,#5A31 | Oct 11, 1991 |
| K910640 | Em Diagnostic Systems | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 | Apr 12, 1991 |