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510(k) K897164

COULTER LD (LDH-L) REAGENT by Coulter Electronics, Inc. — Product Code CFJ

K897164 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "COULTER LD (LDH-L) REAGENT". The FDA issued a decision of Substantially Equivalent on March 9, 1990. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1990
Date Received
December 28, 1989
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 Coulter Electronics, Inc.

  • K923951 — CD8 CYTOSPHERES KIT (April 25, 1994)
  • K930119 — COULTER RETIC-C CELL CONTROL (April 5, 1993)
  • K921279 — CD4 CYTOSPHERES KIT (December 29, 1992)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K922181 — COULTER MH009 (August 17, 1992)
  • K922704 — COULTER MAXM W/ AUTOLOADER (July 27, 1992)
  • K921567 — COULTER MH017 (July 6, 1992)
  • K912133 — PX COULTER(R) CELL CONTROL (July 17, 1991)
  • K911385 — COULTER(R) MH010 (June 17, 1991)
  • K905771 — COULTER DART AST (GOT) REAGENT (February 26, 1991)

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