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510(k) K861974

PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST by Perceptive Systems, Inc. — Product Code LNJ

K861974 is an FDA 510(k) premarket notification submitted by Perceptive Systems, Inc. for the device "PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST". The FDA issued a decision of Substantially Equivalent on August 4, 1986. The device falls under product code LNJ (Analyzer, Chromosome, Automated), a Class II device regulated under 21 CFR 864.5260. Perceptive Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1986
Date Received
May 21, 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 by Perceptive Systems, Inc.

  • K952778 — CHESHIRE (September 6, 1995)

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)
  • K864955 — CYTOSCAN (March 16, 1987)
  • K851508 — NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS (July 12, 1985)
  • K851174 — METACHROME (May 23, 1985)

FDA data resources