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510(k) K883118

ON THE SPOT CANDIDASURE by Medi-Tech, Inc. — Product Code LRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1988
Date Received
July 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Candida Spp., Direct Antigen, Id
Device Class
Class II
Regulation Number
866.3165
Review Panel
MI
Submission Type

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Other clearances for product code LRF

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