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510(k) K964698

SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT by Andwin Scientific — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1997
Date Received
November 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Andwin Scientific

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  • K983428 — SAFETEX CERVICAL SCRAPER (PLASTIC) (November 16, 1998)

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