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510(k) K882059

BILIRUBIN STANDARD by Verichem Laboratories, Inc. — Product Code JIT

K882059 is an FDA 510(k) premarket notification submitted by Verichem Laboratories, Inc. for the device "BILIRUBIN STANDARD". The FDA issued a decision of Substantially Equivalent on October 25, 1988. The device falls under product code JIT (Calibrator, Secondary), 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
October 25, 1988
Date Received
May 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
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)
  • K924904 — HDL-CHOLESTEROL STANDARD, MODIFICATION (January 13, 1993)
  • K912513 — ELECTROLYTE CONTROL (July 19, 1991)
  • K901113 — MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD (March 29, 1990)
  • 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 JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)

FDA data resources