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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K930874
Device Name LD-1 CONTROL-LEVEL 1 & 2
Applicant
Cala Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Applicant Contact JAMES F GODFREY
Correspondent
Cala Diagnostics
P.O. Box 6714
Los Osos,  CA  93412
Correspondent Contact JAMES F GODFREY
Regulation Number862.1660
Classification Product Code
JJX  
Date Received02/19/1993
Decision Date 04/22/1993
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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