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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
510(k) Number K931474
Device Name DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS
Applicant
Gbf Medical Group
410-J Gallimore Dairy Rd.
Greensboro,  NC  27409
Applicant Contact DANNY BOWMAN
Correspondent
Gbf Medical Group
410-J Gallimore Dairy Rd.
Greensboro,  NC  27409
Correspondent Contact DANNY BOWMAN
Regulation Number864.3250
Classification Product Code
KDW  
Date Received03/24/1993
Decision Date 05/10/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Pathology
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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