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510(k) K881380

B. FRAGTEX by American Biomedical Products, Inc. — Product Code JSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1988
Date Received
April 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Anaerobic Identification
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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