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LACTATE DEHYDROGENASE (LD)

FDA 510(k) clearance K970684 · decided 1997-05-07

Clearance details

K-number
K970684
Device name
LACTATE DEHYDROGENASE (LD)
Applicant
Randox Laboratories, Ltd.
Decision
Substantially Equivalent
Date received
1997-02-24
Decision date
1997-05-07
Days to decision
72 days
Clearance type
Traditional
Product code
CFJ
Device class
2
Regulation number
862.1440
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Crumlin, IE
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT (K131975)Alfa Wassermann Diagnostic Technologies, Inc.2013-10-02
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (K091544)Alfa Wassermann, Inc.2009-09-09
PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (K051108)Abaxis, Inc.2005-07-08
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (K974859)Diagnostic Chemicals , Ltd.1998-01-22
LIQUID LDH-L REAGENT SET (K973589)Pointe Scientific, Inc.,1997-10-08
LD-L REAGENT (K971398)Carolina Liquid Chemistries Corp.1997-05-02
LACTATE DEHYDROGENASE (K964912)Derma Media Lab., Inc.1997-01-09
LACTATE DEHYDROGENASE REAGENT SET (K961431)Pointe Scientific, Inc.,1996-06-03
LACTATE DEHYDROGENASE REAGENT SYSTEM (K952747)Medical Diagnostic Technologies, Inc.1995-08-07
HICHEM LDH/L REAGENT KIT (K946022)Hichem Diagnostics1995-02-23
LACTATE DEHYDROGENASE QVET (K942964)Prisma Systems1994-12-29
LACTATE DEHYDROGENASE (LD) (K935175)Em Diagnostic Systems, Inc.1993-12-16

Recalls involving this device

No recalls on record reference this clearance.