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510(k) K834566

PRESERV SAF FIXATIVE 15ML by Preventive Diagnostics Corp. — Product Code LIO

K834566 is an FDA 510(k) premarket notification submitted by Preventive Diagnostics Corp. for the device "PRESERV SAF FIXATIVE 15ML". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Preventive Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
December 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
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)
  • K840220 — HDL CHOLESTEROL 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)
  • 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)
  • K840218 — TRIGLYCERIDE AQUEOUS STANDARDS (March 23, 1984)

Other clearances for product code LIO

  • K222613 — ARX Liquid Amies Collection & Transport System (March 27, 2024)
  • K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM (October 21, 2013)
  • K120846 — TRANSPORT CULTURE MEDIUM DEVICE (June 8, 2012)
  • K103805 — MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION (January 25, 2011)
  • K082472 — VIROCULT, MODEL MW950 (December 30, 2008)
  • K070062 — COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL (July 30, 2007)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)
  • K003761 — NAT - NUCLEIC ACID TRANSPORT (May 31, 2001)
  • K983119 — ENTERO-TEST HP, MODEL #102-01 (March 15, 1999)
  • K981391 — PAR-ONE (July 14, 1998)

FDA data resources