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510(k) K821878

ULTRAZYME PLUS LDH by Harleco Diagnostics — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1982
Date Received
June 25, 1982
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 Harleco Diagnostics

  • K823147 — URIC ACID STANDARD, 8MG/DL #65078 (November 22, 1982)
  • K822852 — TRIGLYCERIDE CALIBRATOR (October 27, 1982)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821871 — ULTRAZYME PLUS 2GT (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (July 14, 1982)
  • K821872 — ULTRACHEM URIC ACID AIDH (July 14, 1982)
  • K821881 — ULTRACHEM CREA (July 14, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821873 — ULTRACHEM T-BILI (July 14, 1982)

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  • K961431 — LACTATE DEHYDROGENASE REAGENT SET (June 3, 1996)
  • K952747 — LACTATE DEHYDROGENASE REAGENT SYSTEM (August 7, 1995)