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510(k) K811953

IMMOPHASE INSULIN (125I) RADIOASSAY by Corning Medical & Scientific — Product Code CFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1981
Date Received
July 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoreactive Insulin
Device Class
Class I
Regulation Number
862.1405
Review Panel
CH
Submission Type

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