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510(k) K800551

TRIGLYCERIDES TEST (500NM) by Reagents Applications, Inc. — Product Code JGY

K800551 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "TRIGLYCERIDES TEST (500NM)". The FDA issued a decision of Substantially Equivalent on March 25, 1980. The device falls under product code JGY (Colorimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1980
Date Received
March 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Reagents Applications, Inc.

  • K982056 — RAICHEM CO2 REAGENT (June 24, 1998)
  • K972853 — CHOLESTEROL RAPID LIQUID REAGENT (September 24, 1997)
  • K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II (July 30, 1992)
  • K915191 — RAI-TROL ELEVATED LIPIDS CONTROL (December 18, 1991)
  • K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT (September 25, 1991)
  • K911899 — RAICHEM SPIA C4 REAGENT (May 9, 1991)
  • K911900 — RAICHEM SPIA C3 REAGENT (May 9, 1991)
  • K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (May 8, 1991)
  • K905085 — RAICHEM GGT REAGENT (December 20, 1990)
  • K905084 — RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV (December 20, 1990)

Other clearances for product code JGY

  • K120664 — PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM (January 24, 2003)
  • K000586 — BIOSCANNER TRIGLYCERIDES TEST STRIPS (July 3, 2000)
  • K991894 — BIOSCANNER TRIGLYCERIDES TEST STRIPS (May 24, 2000)
  • K971005 — TRIGLYCERIDES (April 21, 1997)
  • K954187 — TRIGLYCERIDES REAGENT (October 23, 1995)
  • K941063 — DNA TRIGLYCERIDE PROCEDURE (July 20, 1994)
  • K931116 — IL TEST(TM) TRIGLYCERIDE (March 28, 1994)
  • K914033 — CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (September 27, 1991)
  • K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (December 11, 1990)

FDA data resources