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510(k) K012103

BANDVIEW SYSTEM by Applied Spectral Imaging , Ltd. — Product Code LNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2001
Date Received
July 5, 2001
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

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Other clearances for product code LNJ

  • K050236 — FISHVIEW (June 27, 2005)
  • 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)
  • 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)