Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CFJ — Predicate Candidate Screening
111 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
81 days90th percentile
111clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE T | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-10-02 | 96 | 0 |
| K091544 | S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 | Alfa Wassermann, Inc. | 2009-09-09 | 105 | 0 |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | Abaxis, Inc. | 2005-07-08 | 67 | 0 |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327 | Diagnostic Chemicals , Ltd. | 1998-01-22 | 24 | 0 |
| K973589 | LIQUID LDH-L REAGENT SET | Pointe Scientific, Inc., | 1997-10-08 | 16 | 1 |
| K970684 | LACTATE DEHYDROGENASE (LD) | Randox Laboratories, Ltd. | 1997-05-07 | 72 | 0 |
| K971398 | LD-L REAGENT | Carolina Liquid Chemistries Corp. | 1997-05-02 | 17 | 0 |
| K964912 | LACTATE DEHYDROGENASE | Derma Media Lab., Inc. | 1997-01-09 | 31 | 0 |
| K961431 | LACTATE DEHYDROGENASE REAGENT SET | Pointe Scientific, Inc., | 1996-06-03 | 49 | 0 |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 | 52 | 0 |
| K946022 | HICHEM LDH/L REAGENT KIT | Hichem Diagnostics | 1995-02-23 | 73 | 0 |
| K942964 | LACTATE DEHYDROGENASE QVET | Prisma Systems | 1994-12-29 | 189 | 0 |
| K935175 | LACTATE DEHYDROGENASE (LD) | Em Diagnostic Systems, Inc. | 1993-12-16 | 50 | 0 |
| K924703 | LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 | Em Diagnostic Systems, Inc. | 1993-02-05 | 141 | 0 |
| K924965 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-11-16 | 47 | 0 |
| K923412 | OLYMPUS LACTATE DEHYDROGENASE REAGENT | Olympus Corp. | 1992-09-18 | 70 | 0 |
| K921025 | SYNERMED LDHH-L REAGENT KIT | Synermed, Inc. | 1992-03-23 | 20 | 0 |
| K915803 | DMA LD KINETIC PROCEDURE | Data Medical Associates, Inc. | 1992-03-18 | 85 | 0 |
| K914262 | ABBOTT QUICKSTART LDH,#5A31 | Em Diagnostic Systems, Inc. | 1991-10-11 | 18 | 0 |
| K910640 | SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 | Em Diagnostic Systems, Inc. | 1991-04-12 | 58 | 0 |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | Biotrol, USA, Inc. | 1991-03-11 | 82 | 0 |
| K903773 | SYNERMED LDH REAGENT KIT | Synermed, Inc. | 1990-10-12 | 53 | 0 |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | American Research Products Co. | 1990-04-19 | 65 | 0 |
| K900121 | ROCHE REAGENT FOR LDH | Roche Diagnostic Systems, Inc. | 1990-03-30 | 80 | 0 |
| K897164 | COULTER LD (LDH-L) REAGENT | Coulter Electronics, Inc. | 1990-03-09 | 71 | 0 |
| K896241 | COBAS READY LDH REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | 109 | 0 |
| K894482 | LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 | Em Diagnostic Systems, Inc. | 1989-09-07 | 51 | 0 |
| K884548 | LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 | Em Diagnostic Systems, Inc. | 1988-11-10 | 10 | 0 |
| K883206 | LACTATE DEHYDROGENASE LDH | Electro-Nucleonics, Inc. | 1988-09-09 | 43 | 0 |
| K881474 | VISION(R) LDH (LACTATE DEHYDROGENASE) | Abbott Laboratories | 1988-06-01 | 55 | 0 |
| K880842 | LDH-L REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | 39 | 0 |
| K875206 | LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-02 | 46 | 0 |
| K874848 | LACTATE DEHYDROGENASE LDH-L | Tech-Co, Inc. | 1987-12-18 | 24 | 0 |
| K872030 | UNI-FAST LACTATE DEHYDROGENASE (LDH-L) | Sclavo, Inc. | 1987-07-07 | 42 | 0 |
| K872010 | MULTICHEM LDH-L REAGENT | Simmler, Inc. | 1987-06-11 | 16 | 0 |
| K871781 | ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET | Biochemical Trade, Inc. | 1987-06-03 | 28 | 0 |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | Miles Laboratories, Inc. | 1987-04-14 | 48 | 0 |
| K870401 | WAKO(TM) AUTOKIT LDH | Wako Chemicals USA, Inc. | 1987-03-06 | 32 | 0 |
| K863068 | LDH S.C.E. | J. D. Assoc. | 1986-12-10 | 120 | 0 |
| K863255 | LACTATE DEHYDROGENASE(LD) PROCEDURE | Data Medical Associates, Inc. | 1986-10-03 | 39 | 0 |
| K863477 | EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 | Em Diagnostic Systems, Inc. | 1986-09-26 | 17 | 0 |
| K863545 | EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 | Em Diagnostic Systems, Inc. | 1986-09-25 | 13 | 0 |
| K862306 | KING DIAGNOSTICS LDH TEST | King Diagnostics, Inc. | 1986-08-19 | 63 | 0 |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | Sterling Diagnostics, Inc. | 1986-07-29 | 46 | 0 |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | Hi Chem, Inc. | 1986-06-13 | 16 | 0 |
| K861662 | LACTATE DEHYDROGENASE (LD) PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | 29 | 0 |
| K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE | Hi Chem, Inc. | 1986-04-28 | 13 | 0 |
| K860713 | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. | Catachem, Inc. | 1986-04-24 | 57 | 0 |
| K860728 | L D H-L (LACTIC DEHYDROGENASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | 40 | 0 |
| K860729 | LDH-P (LACTIC DEHYDROGENASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | 40 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda