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510(k) K842902

MICROSTAT GAMMA COUNTER by Micromedic Systems — Product Code JJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1984
Date Received
July 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter (Beta, Gamma) For Clinical Use
Device Class
Class I
Regulation Number
862.2320
Review Panel
CH
Submission Type

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  • K896202 — MATRIX(TM)-96 (January 2, 1990)
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  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872429 — ISO-DATA 100 SERIES GAMMA COUNTER (August 21, 1987)