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510(k) K821883

ULTRAZYME PLUS CK-I by Harleco Diagnostics — Product Code CGS

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, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
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)
  • K821881 — ULTRACHEM CREA (July 14, 1982)
  • K821878 — ULTRAZYME PLUS LDH (July 14, 1982)
  • K821871 — ULTRAZYME PLUS 2GT (July 14, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K821872 — ULTRACHEM URIC ACID AIDH (July 14, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (July 14, 1982)

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