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510(k) K822852

TRIGLYCERIDE CALIBRATOR by Harleco Diagnostics — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1982
Date Received
September 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Harleco Diagnostics

  • K823147 — URIC ACID STANDARD, 8MG/DL #65078 (November 22, 1982)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821871 — ULTRAZYME PLUS 2GT (July 14, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821872 — ULTRACHEM URIC ACID AIDH (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (July 14, 1982)
  • K821881 — ULTRACHEM CREA (July 14, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K821878 — ULTRAZYME PLUS LDH (July 14, 1982)
  • K821873 — ULTRACHEM T-BILI (July 14, 1982)

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  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)