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510(k) K803244

ASSAY STRIPS by Corning Costar Corp. — Product Code JTC

K803244 is an FDA 510(k) premarket notification submitted by Corning Costar Corp. for the device "ASSAY STRIPS". The FDA issued a decision of Substantially Equivalent on February 2, 1981. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Corning Costar Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
December 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Microtiter Diluting/Dispensing
Device Class
Class I
Regulation Number
866.2500
Review Panel
MI
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)
  • K823138 — CELL SCRAPER (November 29, 1982)
  • 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 JTC

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • K901808 — MICROMATE 196 MODEL A961960 (June 20, 1990)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K892369 — MULTI-PROBE HEAD PLUS (June 2, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (May 1, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (May 1, 1989)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K884695 — WASHER 500 MICROELISA SYSTEM (December 13, 1988)
  • K884125 — BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (December 2, 1988)
  • K874598 — DYNATECH MR 250 MANUAL MICROELISA READER (November 20, 1987)

FDA data resources