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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase (Prostatic), Tartrate Inhibited
510(k) Number K802153
Device Name CBC PAP TEST KIT
Applicant
Calbiochem-Behring Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Calbiochem-Behring Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1020
Classification Product Code
JFH  
Date Received09/08/1980
Decision Date 11/12/1980
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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