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510(k) K883206

LACTATE DEHYDROGENASE LDH by Electro-Nucleonics, Inc. — Product Code CFJ

K883206 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics, Inc. for the device "LACTATE DEHYDROGENASE LDH". The FDA issued a decision of Substantially Equivalent on September 9, 1988. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Electro-Nucleonics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1988
Date Received
July 28, 1988
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 Electro-Nucleonics, Inc.

  • K893718 — DELTATEST (R) LIPASE II (September 28, 1989)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT (September 9, 1988)

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)
  • K952747 — LACTATE DEHYDROGENASE REAGENT SYSTEM (August 7, 1995)

FDA data resources