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510(k) K840278

HDL CHOLESTEROL CONTROLS-LEVELS by Preventive Diagnostics Corp. — Product Code JIX

Clearance Details

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

  • K840677 — HDL EZ-TZ3 CHOLESTEROL REAGENT KIT (April 13, 1984)
  • K840676 — PDC HDL EZ-SEP CHOLESTEROL REAGENT (April 4, 1984)
  • K840218 — TRIGLYCERIDE AQUEOUS STANDARDS (March 23, 1984)
  • K840991 — PRESERV BUFFERED GLYCEROL SALINE (March 23, 1984)
  • K840968 — PRESERV TRANSPORT & CULTURE PACK (March 23, 1984)
  • K840219 — TRIGLYCERIDE/CHOLESTEROL AQUEOUS (March 23, 1984)
  • K840220 — HDL CHOLESTEROL AQUEOUS STANDARDS (March 23, 1984)
  • K840189 — TOTAL CHOLESTEROL REAGENT SET (March 23, 1984)
  • K840217 — CHOLESTEROL AQUEOUS STANDARD (March 23, 1984)
  • K840990 — PRESERV CARY BLAIR TRANSPORT PACK (March 23, 1984)

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