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510(k) K882194

GEMINII GAMMA COUNTER by Laboratory Technologies, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
May 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

Other clearances by Laboratory Technologies, Inc.

  • K921536 — ACCULYTE CHEMILUMINESCENCE ANALYZER (October 12, 1993)
  • K900087 — GENESYS 6000 GAMMA COUNTER (July 19, 1990)
  • K851689 — GENESYS GAMMA COUNTER (August 7, 1985)

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