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510(k) K940008

GLYCATED PROTEIN CALIBRATORS by Primus Corp. — Product Code JIS

K940008 is an FDA 510(k) premarket notification submitted by Primus Corp. for the device "GLYCATED PROTEIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on May 9, 1994. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Primus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1994
Date Received
January 4, 1994
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 Primus Corp.

  • K062658 — PRIMUS A1CARE ASSAY (November 26, 2007)
  • K013787 — NYCOCARD CRP (May 14, 2002)
  • K014084 — NYCOCARD CRP CONTROL (January 7, 2002)
  • K993131 — NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY (May 22, 2000)
  • K994045 — PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 (December 21, 1999)
  • K992921 — PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II (November 12, 1999)
  • K955283 — PRIMUS VARIANT SYSTEM PVS99 (March 1, 1996)
  • K942009 — PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY (September 14, 1994)
  • K940142 — GLYCATED PROTEIN CONTROLS (April 26, 1994)
  • K936204 — GLYCATED HEMOGLOBIN CALIBRATORS (March 22, 1994)

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