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510(k) K861253

TISSUE CULTURE FLASK PL 732 PLASTIC by Travenol Laboratories, S.A. — Product Code KJA

K861253 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "TISSUE CULTURE FLASK PL 732 PLASTIC". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code KJA (Flask, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
April 3, 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 by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

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)
  • K853441 — FETAL BOVINE SERUM IN TRANSFER CONTAINER (August 26, 1985)

FDA data resources