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510(k) K834412

PRESERV PVA FIXATIVE 15ML-FORMALIN PK by Preventive Diagnostics Corp. — Product Code KDT

K834412 is an FDA 510(k) premarket notification submitted by Preventive Diagnostics Corp. for the device "PRESERV PVA FIXATIVE 15ML-FORMALIN PK". The FDA issued a decision of Substantially Equivalent on January 13, 1984. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. Preventive Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1984
Date Received
December 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
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)
  • K840217 — CHOLESTEROL AQUEOUS STANDARD (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)
  • K840218 — TRIGLYCERIDE AQUEOUS STANDARDS (March 23, 1984)

Other clearances for product code KDT

  • K873593 — BIOSURE SPECIMEN COLLECTION CONTAINER (November 25, 1987)
  • K862665 — NOVACYTE-U (September 4, 1986)
  • K834579 — BIOSPAL 2400S (February 4, 1984)
  • K833660 — PRESERV PVA FIXATIVE -MALIN PACK (November 28, 1983)
  • K823773 — PROVIAL II #006-010-0201 (January 21, 1983)
  • K822870 — STOOL-COLLECTION/PRESERVATION KIT (November 1, 1982)
  • K821621 — PREGNOPOST (July 21, 1982)
  • K820246 — PREFILLED SPECIMEN CONTAINER (February 18, 1982)
  • K811793 — FIX-RIGHT 90ML & 180 ML PREFILLED CONT (July 31, 1981)
  • K800946 — URINARY CATHETER SAMPLING KIT (June 20, 1980)

FDA data resources