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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K864133
Device Name DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT
Applicant
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Applicant Contact GOPAL SAVJANI
Correspondent
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Correspondent Contact GOPAL SAVJANI
Regulation Number862.1690
Classification Product Code
JLW  
Date Received10/21/1986
Decision Date 12/18/1986
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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