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510(k) K851174

METACHROME by Potomac Medical System — Product Code LNJ

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

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  • 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)