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510(k) K864021

TISSUE CULTURE FLASK by Fenwal Laboratories — Product Code KJA

K864021 is an FDA 510(k) premarket notification submitted by Fenwal Laboratories for the device "TISSUE CULTURE FLASK". The FDA issued a decision of Substantially Equivalent on October 29, 1986. The device falls under product code KJA (Flask, Tissue Culture), a Class I device regulated under 21 CFR 864.2240.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1986
Date Received
October 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flask, Tissue Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

Other clearances for product code KJA

  • K972404 — VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) (July 22, 1997)
  • K933228 — KAPTON PEEL POUCH (March 30, 1994)
  • K885121 — CELL SCRAPER (December 28, 1988)
  • K873890 — TISSUE CULTURE FLASKS (November 25, 1987)
  • K873889 — TISSUE CULTURE TUBES (November 25, 1987)
  • K871324 — DU PONT STERICELL CELL CULTURE SYSTEM (April 14, 1987)
  • K870865 — TISSUE CULTURE BAG (March 30, 1987)
  • K862152 — TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD (June 16, 1986)
  • K861253 — TISSUE CULTURE FLASK PL 732 PLASTIC (April 11, 1986)
  • K853441 — FETAL BOVINE SERUM IN TRANSFER CONTAINER (August 26, 1985)

FDA data resources