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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K884970
Device Name PINSET
Applicant
Safety Diagnostics, Inc.
Microtech Bldg.
1701 Grand Ave. (Hwy 132)
Waukegan,  IL  60085
Applicant Contact MITCHEN, PHD
Correspondent
Safety Diagnostics, Inc.
Microtech Bldg.
1701 Grand Ave. (Hwy 132)
Waukegan,  IL  60085
Correspondent Contact MITCHEN, PHD
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/30/1988
Decision Date 09/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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