FDA 510(k) Applications for Medical Device Product Code "CFJ"
(Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K051108 | ABAXIS, INC. | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | 07/08/2005 |
| K131975 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | 10/02/2013 |
| K091544 | ALFA WASSERMANN, INC. | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | 09/09/2009 |
| K971398 | CAROLINA LIQUID CHEMISTRIES CORP. | LD-L REAGENT | 05/02/1997 |
| K964912 | DERMA MEDIA LAB., INC. | LACTATE DEHYDROGENASE | 01/09/1997 |
| K974859 | DIAGNOSTIC CHEMICALS LTD. | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 | 01/22/1998 |
| K961431 | POINTE SCIENTIFIC, INC. | LACTATE DEHYDROGENASE REAGENT SET | 06/03/1996 |
| K973589 | POINTE SCIENTIFIC, INC. | LIQUID LDH-L REAGENT SET | 10/08/1997 |
| K970684 | RANDOX LABORATORIES, LTD. | LACTATE DEHYDROGENASE (LD) | 05/07/1997 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
