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510(k) K871559

CELL LIFTER by Corning Costar Corp. — Product Code LIB

K871559 is an FDA 510(k) premarket notification submitted by Corning Costar Corp. for the device "CELL LIFTER". The FDA issued a decision of Substantially Equivalent on May 15, 1987. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Corning Costar Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1987
Date Received
April 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Corning Costar Corp.

  • K860703 — U - STAR (MICRO-STAR) (May 6, 1986)
  • K823137 — OCTAPETTES (December 3, 1982)
  • K823138 — CELL SCRAPER (November 29, 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 LIB

  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)
  • K920416 — SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (April 8, 1992)
  • K912558 — GULL ELISAWARE (September 16, 1991)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)

FDA data resources