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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Progesterone
510(k) Number K950570
Device Name STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
Applicant
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact RICHARD D BLISS JR.
Correspondent
Baxter Diagnostics, Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact RICHARD D BLISS JR.
Regulation Number862.1620
Classification Product Code
JLS  
Date Received02/03/1995
Decision Date 04/11/1995
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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