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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, delta-aminolevulinic, ion-exchange columns with colorimetry
510(k) Number K921534
Device Name DSL DHEA (DSL 8900)
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Applicant Contact JOHNNY R WILLLIS
Correspondent
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Correspondent Contact JOHNNY R WILLLIS
Regulation Number862.1060
Classification Product Code
JKL  
Date Received03/31/1992
Decision Date 05/26/1992
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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