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510(k) K864955

CYTOSCAN by Image Recognition Systems , Ltd. — Product Code LNJ

K864955 is an FDA 510(k) premarket notification submitted by Image Recognition Systems , Ltd. for the device "CYTOSCAN". The FDA issued a decision of Substantially Equivalent on March 16, 1987. The device falls under product code LNJ (Analyzer, Chromosome, Automated), a Class II device regulated under 21 CFR 864.5260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1987
Date Received
December 18, 1986
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 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)
  • K902311 — GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (August 20, 1990)
  • K895095 — AKS II (February 9, 1990)
  • K872755 — KARYOTEC 100 (September 1, 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