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510(k) K972333

AMMONIA/IRON STANDARD KIT by Verichem Laboratories, Inc. — Product Code JIX

K972333 is an FDA 510(k) premarket notification submitted by Verichem Laboratories, Inc. for the device "AMMONIA/IRON STANDARD KIT". The FDA issued a decision of Substantially Equivalent on July 23, 1997. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), 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
July 23, 1997
Date Received
June 23, 1997
Clearance Type
Traditional
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.

  • 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)
  • 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)

Other clearances for product code JIX

  • K161140 — VITROS Chemistry Products Calibrator Kit 3 (May 20, 2016)
  • K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (December 18, 2015)
  • K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech C (July 8, 2015)
  • K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium F (June 15, 2015)
  • K141388 — SYSTEM CALIBRATER (July 11, 2014)
  • K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PR (November 26, 2013)
  • K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C (April 4, 2013)
  • K123321 — DIMENSION CHEMISTRY III CALIBRATORY (February 15, 2013)
  • K123372 — ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR (January 14, 2013)
  • K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS (October 12, 2012)

FDA data resources