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510(k) K823773

PROVIAL II #006-010-0201 by Dynatech Corp. — Product Code KDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1983
Date Received
December 14, 1982
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

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Other clearances for product code KDT

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  • K834579 — BIOSPAL 2400S (February 4, 1984)
  • K834412 — PRESERV PVA FIXATIVE 15ML-FORMALIN PK (January 13, 1984)
  • K833660 — PRESERV PVA FIXATIVE -MALIN PACK (November 28, 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)