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510(k) K841058

LDH-UV REAGENT SET by Medical Specialties, Inc. — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1984
Date Received
March 12, 1984
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 Specialties, Inc.

  • K946201 — STAND, INFUSION (April 18, 1995)
  • K931947 — CHECKPOINT (June 18, 1993)
  • K926095 — REFRACTROL-SP (January 26, 1993)
  • K924926 — MSI-HCT (January 7, 1993)
  • K896566 — MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE (February 9, 1990)
  • K883851 — MSI-CAL 8 (November 22, 1988)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K880608 — MSI-PC (March 21, 1988)
  • K880270 — MSI-DIFF PLUS (March 1, 1988)

Other clearances for product code CFJ

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  • 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)