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510(k) K981436

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 by Casco Standards — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1998
Date Received
April 14, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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