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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, prolactin (lactogen)
510(k) Number K960561
Device Name DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Applicant Contact JOHN WILLIS
Correspondent
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Correspondent Contact JOHN WILLIS
Regulation Number862.1625
Classification Product Code
CFT  
Date Received02/09/1996
Decision Date 04/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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