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510(k) K821875

ULTRACHEM TRI-ES by Harleco Diagnostics — Product Code CDT

K821875 is an FDA 510(k) premarket notification submitted by Harleco Diagnostics for the device "ULTRACHEM TRI-ES". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Harleco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
June 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
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)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821878 — ULTRAZYME PLUS LDH (July 14, 1982)
  • K821883 — ULTRAZYME PLUS CK-I (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (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)

Other clearances for product code CDT

  • K150819 — Triglycerides (August 6, 2015)
  • K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (November 22, 2013)
  • K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES (May 31, 2013)
  • K113830 — VANTERA CLINICAL ANALYZER (August 30, 2012)
  • K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL (May 19, 2011)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K043546 — DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (January 18, 2005)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K010871 — TGL FLEX REAGENT CARTRIDGE (July 9, 2001)

FDA data resources