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510(k) K012103

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

K012103 is an FDA 510(k) premarket notification submitted by Applied Spectral Imaging , Ltd. for the device "BANDVIEW SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 2001. The device falls under product code LNJ (Analyzer, Chromosome, Automated), a Class II device regulated under 21 CFR 864.5260. Applied Spectral Imaging , Ltd. has at least 7 other 510(k) clearances on record.

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

Other clearances by Applied Spectral Imaging , Ltd.

  • K140957 — GENASIS HIPATH IHC FAMILY (January 15, 2015)
  • K122554 — GENASIS SCANVIEW SYSTEM (February 7, 2013)
  • K110345 — SCANVIEW SYSTEM (October 19, 2011)
  • K101291 — SCANVIEW HER2/NEU FISH SYSTEM (November 23, 2010)
  • K071398 — SCANVIEW, MODEL SC-300 (October 4, 2007)
  • K050236 — FISHVIEW (June 27, 2005)
  • K973950 — RETINAL CUBE (December 12, 1997)

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)

FDA data resources