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510(k) K112834

MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES by Verichem Laboratories, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2012
Date Received
September 28, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Verichem Laboratories, Inc.

  • K974290 — MICROPROTEIN STANDARD KIT (December 19, 1997)
  • K973345 — MATRIX PLUS MULTI-CALIBRATOR KIT (October 29, 1997)
  • K972333 — AMMONIA/IRON STANDARD KIT (July 23, 1997)
  • K924904 — HDL-CHOLESTEROL STANDARD, MODIFICATION (January 13, 1993)
  • 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)

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