Panels › Clinical Chemistry › Product code CFJ · Class 2
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Regulation 862.1440
0510(k)s in 12 months (111 all time)
0recalls in 12 months (8 all time)
4recalls that name a 510(k)
Top companies in CFJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 1986 | K860029 | LDH (OPTIMIZED) REAGENT Sigma Chemical Co. | CFJ |
| Jan 21, 1986 | K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET Technostics Intl. | CFJ |
| Jan 14, 1986 | K855159 | LACTIC DEHYDROGENASE REAGENT SET Technostics Intl. | CFJ |
| Dec 5, 1985 | K854585 | ULTRAZYME PLUS & SYSTEMATE LDH Em Diagnostic Systems, Inc. | CFJ |
| Aug 7, 1985 | K852948 | AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI Amresco, Inc. | CFJ |
| May 31, 1985 | K851996 | LD-L REAGENT Alpkem Corp. | CFJ |
| May 30, 1985 | K851997 | LD-P REAGENT Alpkem Corp. | CFJ |
| Mar 1, 1985 | K850378 | LDH REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CFJ |
| Sep 13, 1984 | K843269 | SYSTEMATE LDH, 67210 Em Diagnostic Systems, Inc. | CFJ |
| Jul 20, 1984 | K842507 | LACTATE DEHYDROGENASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) | CFJ |
| Jul 18, 1984 | K842244 | LACTATE DENYDRO GENASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) | CFJ |
| Jun 14, 1984 | K841917 | SIGMS PROCED. 228 UV LACTATE DEHYDRO Sigma Diagnostics, Inc. | CFJ |
| Jun 8, 1984 | K841703 | TDX REA LDH Abbott Laboratories | CFJ |
| May 1, 1984 | K841058 | LDH-UV REAGENT SET Medical Specialties, Inc. | CFJ |
| Mar 23, 1984 | K840006 | KINETIC LDH, A< BLUE 610 METHOD American Monitor Corp. | CFJ |
| Jul 19, 1983 | K832048 | ASTRA SYSTEMS ENZYME MODULE LD-P Beckman Instruments, Inc. | CFJ |
| Jun 16, 1983 | K831419 | RAICHEM LDH-P REAGENT W/SEPARATE START- Reagents Applications, Inc. | CFJ |
| Jun 16, 1983 | K831415 | LACTIC DEHYDROGENASE REAGENT SET Sterling Biochemical, Inc. | CFJ |
| Jun 8, 1983 | K831353 | ASTRA SYSTEMS ENZYME MODULE Beckman Instruments, Inc. | CFJ |
| Jan 9, 1983 | K823721 | FLOW-PAC LDH REAGENT SET Amresco, Inc. | CFJ |
| Sep 17, 1982 | K822492 | OPTIMIZED UV-LDH REAGENT SET Biorent Diagnostic, Inc. | CFJ |
| Aug 27, 1982 | K822312 | RAICHEM LDH-L REAGENT Reagents Applications, Inc. | CFJ |
| Jul 20, 1982 | K821201 | LDH-UV REAGENT SET Omega Medical Electronics | CFJ |
| Jul 14, 1982 | K821878 | ULTRAZYME PLUS LDH Harleco Diagnostics | CFJ |
| Jun 1, 1982 | K821466 | ULTRAZYME PLUS LDH, #64950,65038&65039 Emd Chemicals, Inc. | CFJ |
| Mar 8, 1982 | K820378 | LD-L TRIS SYSTEM PACK TEST Boehringer Mannheim Corp. | CFJ |
| Dec 31, 1981 | K813496 | LDH-L Pointe Scientific, Inc., | CFJ |
| Sep 24, 1981 | K812590 | ULTRA ZYME PLUS LDH #64950, 65038 & 39 Harleco | CFJ |
| Sep 14, 1981 | K812472 | SPIN-CHEM LD-L REAGENT Smithkline Diagnostics, Inc. | CFJ |
| Jan 28, 1981 | K810083 | LDH-L LIQUID ENZYMATIC, KINETIC KIT Bio-Analytics Laboratories, Inc. | CFJ |
| Dec 22, 1980 | K803019 | SERALYZER LDH REAGENT STRIPS, CALIBR Miles Laboratories, Inc. | CFJ |
| Nov 12, 1980 | K802572 | BECKMAN LIQUID-STAT LD-L-UV ENZYME Beckman Instruments, Inc. | CFJ |
| May 28, 1980 | K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS Diagnostic Solutions, Inc. | CFJ |
| Feb 13, 1980 | K800120 | LDH (L-P) REAGENT Gilford Diagnostics | CFJ |
| Jan 17, 1980 | K792658 | COBAS-BLO REAGENTS (LACTATE DEHYDRO Hoffmann-La Roche, Inc. | CFJ |
| Jul 17, 1979 | K791085 | PLUS CHEM, DETERMINATION OF LD (LDH-P) Smithkline Diagnostics, Inc. | CFJ |
| Jul 17, 1979 | K791081 | SPIN CHEM REAGENT, DETERMINATION OF LDH- Smithkline Diagnostics, Inc. | CFJ |
| May 15, 1979 | K790771 | LD-P REAGENT (LDH P-L REAGENT) Gilford Diagnostics | CFJ |
| Apr 4, 1979 | K790248 | NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) Boehringer Laboratories | CFJ |
| Feb 8, 1979 | K790020 | SERUM, LACTIC DEHYDROGENASE Fisher Scientific Co., LLC | CFJ |
| Nov 22, 1978 | K781775 | LDH Gilford Diagnostics | CFJ |
| Nov 22, 1978 | K781765 | LDH REAGENT SYSTEM American Monitor Corp. | CFJ |
| Nov 3, 1978 | K781724 | NAD REDUCTION METHOD, LACTATE PYRIVATE Medical Analysis Systems, Inc. | CFJ |
| Oct 3, 1978 | K781538 | SINGLE VIAL LDH-L TRIS Boehringer Mannheim Corp. | CFJ |
| Aug 10, 1978 | K781128 | LDH (UV KINETIC) Macomb Chemical Co. | CFJ |
| Apr 18, 1978 | K780563 | SINGLE VIAL LACTATE Boehringer Mannheim Corp. | CFJ |
| Feb 14, 1978 | K780101 | ULTRAZYME PLUS LDH Harleco | CFJ |
| Feb 1, 1978 | K780041 | LACTATE DEHYDROGENASE Beckman Instruments, Inc. | CFJ |
| Nov 22, 1977 | K771836 | LACTATE DEHYDROGENASE Gamma Enterprises, Inc. | CFJ |
| Nov 15, 1977 | K772028 | GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH Harleco | CFJ |
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