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510(k) K853441

FETAL BOVINE SERUM IN TRANSFER CONTAINER by Newport Biosystems, Inc. — Product Code KJA

K853441 is an FDA 510(k) premarket notification submitted by Newport Biosystems, Inc. for the device "FETAL BOVINE SERUM IN TRANSFER CONTAINER". The FDA issued a decision of Substantially Equivalent on August 26, 1985. The device falls under product code KJA (Flask, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Newport Biosystems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1985
Date Received
August 13, 1985
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 by Newport Biosystems, Inc.

  • K881648 — TRANSFER CONTAINER HUMIDIFIER (December 30, 1988)
  • K860282 — RPMI 1640 W/GLUTAMINE W/HEPES (February 5, 1986)
  • K855085 — TISSUE CULTURE MEDIA (January 13, 1986)

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)
  • K864021 — TISSUE CULTURE FLASK (October 29, 1986)
  • K862152 — TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD (June 16, 1986)
  • K861253 — TISSUE CULTURE FLASK PL 732 PLASTIC (April 11, 1986)

FDA data resources