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510(k) K823138

CELL SCRAPER by Corning Costar Corp. — Product Code KJA

K823138 is an FDA 510(k) premarket notification submitted by Corning Costar Corp. for the device "CELL SCRAPER". The FDA issued a decision of Substantially Equivalent on November 29, 1982. The device falls under product code KJA (Flask, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Corning Costar Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
October 25, 1982
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 Corning Costar Corp.

  • K871559 — CELL LIFTER (May 15, 1987)
  • K860703 — U - STAR (MICRO-STAR) (May 6, 1986)
  • K823137 — OCTAPETTES (December 3, 1982)
  • K803244 — ASSAY STRIPS (February 2, 1981)
  • K803242 — SEROCLUSTER EIA PLATES (January 28, 1981)
  • K803243 — SEROCLUSTER FLEXIBLE VINYL U & V PL. (January 28, 1981)
  • K800240 — SEROCLUSTER U AND V (February 13, 1980)

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