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510(k) K780173

LYPOPROTEIN CHOLESTEROL TEST KIT by Environmental Chemical Specialties — Product Code JHM

K780173 is an FDA 510(k) premarket notification submitted by Environmental Chemical Specialties for the device "LYPOPROTEIN CHOLESTEROL TEST KIT". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code JHM (Colorimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Environmental Chemical Specialties has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
February 2, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Lipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Environmental Chemical Specialties

  • K812635 — ANEMIA CONTROL (October 2, 1981)
  • K811810 — URIC ACID TEST (July 15, 1981)
  • K811811 — TDM ANTI-CONVULSANT CONTROL LEVELS I-II (July 10, 1981)
  • K811809 — ANTI-ARRHYTHMIC CONTROL LEVELS I & II (July 10, 1981)
  • K803089 — GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (January 2, 1981)
  • K792377 — CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (September 26, 1980)
  • K801854 — SPINAL FLUID CONTROL(HUMAN) (September 16, 1980)
  • K801061 — TOTAL PROTEIN TEST (July 21, 1980)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)

Other clearances for product code JHM

  • K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (July 2, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALO (October 30, 2003)
  • K022519 — LDL CHOLESTEROL (AUTOMATED) (September 30, 2002)
  • K983849 — DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CAR (January 11, 1999)
  • K902935 — ROCHE COBAS READY HDL CHOLESTEROL REAGENT (September 27, 1990)
  • K841056 — HDL PRECIPITANT REAGENT SET (May 1, 1984)

FDA data resources