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510(k) K902311

GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. by Applied Imaging Corp. — Product Code LNJ

K902311 is an FDA 510(k) premarket notification submitted by Applied Imaging Corp. for the device "GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.". The FDA issued a decision of Substantially Equivalent on August 20, 1990. The device falls under product code LNJ (Analyzer, Chromosome, Automated), a Class II device regulated under 21 CFR 864.5260. Applied Imaging Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1990
Date Received
May 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chromosome, Automated
Device Class
Class II
Regulation Number
864.5260
Review Panel
PA
Submission Type

Other clearances by Applied Imaging Corp.

  • K043519 — ARIOL HER-2/NEU FISH (April 25, 2005)
  • K042542 — CYTOVISION FOR CEP XY (January 10, 2005)
  • K033200 — ARIOL (March 18, 2004)
  • K031715 — ARIOL HER-2/NEU IHC (January 8, 2004)
  • K001420 — SLIDESCAN (August 30, 2000)
  • K980375 — WINSCAN AUTOMATED IMAGING SYSTEM (June 9, 1998)

Other clearances for product code LNJ

  • K050236 — FISHVIEW (June 27, 2005)
  • K012103 — BANDVIEW SYSTEM (September 14, 2001)
  • K940240 — IKAROS (February 24, 1995)
  • K912085 — ACLAIMS-IS (October 31, 1991)
  • K895095 — AKS II (February 9, 1990)
  • K872755 — KARYOTEC 100 (September 1, 1987)
  • K864955 — CYTOSCAN (March 16, 1987)
  • K861974 — PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST (August 4, 1986)
  • K851508 — NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS (July 12, 1985)
  • K851174 — METACHROME (May 23, 1985)

FDA data resources