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510(k) K982056

RAICHEM CO2 REAGENT by Reagents Applications, Inc. — Product Code KHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1998
Date Received
June 9, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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