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510(k) K913664

ROSYS MODELS 100 AND 200 by Packard Instrument Co., Inc. — Product Code JQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1991
Date Received
August 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type

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  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K961694 — IMPACT (June 21, 1996)
  • K953345 — GENESIS (November 21, 1995)