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510(k) K951122

Device
CAPITOL URINE DRUG SCREEN COLLECTION KIT
Applicant
HARRY A. SCHLAKMAN
510(k) number
K951122
Product code
KDW  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-05
Date received
1995-02-27
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
HARRY A SCHLAKMAN
Address
304 Verona Ave. Elizabeth NJ US 07208 07208

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
K931474DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITSGbf Medical Group1994-05-10
K913967DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEMDoxtech, Inc.1991-10-18

Legacy Summary#

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FDA Review#

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