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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 K790485
Device Name AMYLOCHROME STAT SEPARATOR, TEST
Applicant
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/12/1979
Decision Date 05/03/1979
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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