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510(k) K931474

Device
DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS
Applicant
GBF MEDICAL GROUP
510(k) number
K931474
Product code
KDW  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1994-05-10
Date received
1993-03-24
Regulation
864.3250
Classification name
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Medical specialty
Pathology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DANNY BOWMAN
Address
410-J Gallimore Dairy Rd. Greensboro NC US 27409 27409

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970580SASI-DC1TSSubstance Abuse Specialties, Inc.1997-04-17
K951122CAPITOL URINE DRUG SCREEN COLLECTION KITHarry A. Schlakman1995-05-05
K913967DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEMDoxtech, Inc.1991-10-18

Legacy Summary#

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FDA Review#

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