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510(k) K924904

HDL-CHOLESTEROL STANDARD, MODIFICATION by Verichem Laboratories, Inc. — Product Code JIS

K924904 is an FDA 510(k) premarket notification submitted by Verichem Laboratories, Inc. for the device "HDL-CHOLESTEROL STANDARD, MODIFICATION". The FDA issued a decision of Substantially Equivalent on January 13, 1993. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Verichem Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1993
Date Received
September 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Verichem Laboratories, Inc.

  • K112834 — MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND K (March 28, 2012)
  • K974290 — MICROPROTEIN STANDARD KIT (December 19, 1997)
  • K973345 — MATRIX PLUS MULTI-CALIBRATOR KIT (October 29, 1997)
  • K972333 — AMMONIA/IRON STANDARD KIT (July 23, 1997)
  • K912513 — ELECTROLYTE CONTROL (July 19, 1991)
  • K901113 — MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD (March 29, 1990)
  • K882059 — BILIRUBIN STANDARD (October 25, 1988)
  • K881320 — URINE TOXICOLOGY STANDARD (September 9, 1988)
  • K875285 — MULTI-CHEMISTRY LINEARITY STANDARD (September 2, 1988)
  • K882117 — ETHYL ALCOHOL STANDARD (August 4, 1988)

Other clearances for product code JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources