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510(k) K913967

Device
DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
Applicant
DOXTECH, INC.
510(k) number
K913967
Product code
KDW  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-18
Date received
1991-09-05
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
STANLEY D OGDEN
Address
4000 Easton Dr., #10 Bakersfield CA US 93309 93309

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
K931474DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITSGbf Medical Group1994-05-10

Legacy Summary#

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FDA Review#

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