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510(k) K840217

CHOLESTEROL AQUEOUS STANDARD by Preventive Diagnostics Corp. — Product Code JIS

K840217 is an FDA 510(k) premarket notification submitted by Preventive Diagnostics Corp. for the device "CHOLESTEROL AQUEOUS STANDARD". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Preventive Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
January 19, 1984
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 Preventive Diagnostics Corp.

  • K840677 — HDL EZ-TZ3 CHOLESTEROL REAGENT KIT (April 13, 1984)
  • K840676 — PDC HDL EZ-SEP CHOLESTEROL REAGENT (April 4, 1984)
  • K840991 — PRESERV BUFFERED GLYCEROL SALINE (March 23, 1984)
  • K840218 — TRIGLYCERIDE AQUEOUS STANDARDS (March 23, 1984)
  • K840968 — PRESERV TRANSPORT & CULTURE PACK (March 23, 1984)
  • K840219 — TRIGLYCERIDE/CHOLESTEROL AQUEOUS (March 23, 1984)
  • K840990 — PRESERV CARY BLAIR TRANSPORT PACK (March 23, 1984)
  • K840189 — TOTAL CHOLESTEROL REAGENT SET (March 23, 1984)
  • K840278 — HDL CHOLESTEROL CONTROLS-LEVELS (March 23, 1984)
  • K840220 — HDL CHOLESTEROL AQUEOUS STANDARDS (March 23, 1984)

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