Home / 510(k) Clearances / K952747

510(k) K952747

LACTATE DEHYDROGENASE REAGENT SYSTEM by Medical Diagnostic Technologies, Inc. — Product Code CFJ

K952747 is an FDA 510(k) premarket notification submitted by Medical Diagnostic Technologies, Inc. for the device "LACTATE DEHYDROGENASE REAGENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 1995. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Medical Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1995
Date Received
June 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

Other clearances by Medical Diagnostic Technologies, Inc.

  • K062229 — CTC WORKSTATION, MODEL 2200 (September 11, 2006)
  • K972209 — SPECTROLYSE HEPARIN (ANTI-IIA) (August 12, 1997)
  • K963106 — CHROMOLIZE PAI-1 KIT (November 18, 1996)
  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (August 14, 1996)
  • K962489 — CHROMOLIZE TPA ASSAY KIT (July 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 1996)

Other clearances for product code CFJ

  • K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, A (October 2, 2013)
  • K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (September 9, 2009)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (July 8, 2005)
  • K974859 — LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (January 22, 1998)
  • K973589 — LIQUID LDH-L REAGENT SET (October 8, 1997)
  • K970684 — LACTATE DEHYDROGENASE (LD) (May 7, 1997)
  • K971398 — LD-L REAGENT (May 2, 1997)
  • K964912 — LACTATE DEHYDROGENASE (January 9, 1997)
  • K961431 — LACTATE DEHYDROGENASE REAGENT SET (June 3, 1996)
  • K946022 — HICHEM LDH/L REAGENT KIT (February 23, 1995)

FDA data resources