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510(k) K851174

METACHROME by Potomac Medical System — Product Code LNJ

K851174 is an FDA 510(k) premarket notification submitted by Potomac Medical System for the device "METACHROME". The FDA issued a decision of Substantially Equivalent on May 23, 1985. The device falls under product code LNJ (Analyzer, Chromosome, Automated), a Class II device regulated under 21 CFR 864.5260. Potomac Medical System has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1985
Date Received
March 25, 1985
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 Potomac Medical System

  • K790637 — COMPUTERIZED ELECTRO-OCULOGRAPH (August 28, 1979)

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)
  • K861974 — PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST (August 4, 1986)
  • K851508 — NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS (July 12, 1985)

FDA data resources