SALIVA SAMPLER

Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

SALIVA DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Saliva Diagnostic Systems, Inc. with the FDA for Saliva Sampler.

Pre-market Notification Details

Device IDK942435
510k NumberK942435
Device Name:SALIVA SAMPLER
ClassificationOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Applicant SALIVA DIAGNOSTIC SYSTEMS, INC. 11719 NE 95TH ST. Vancouver,  WA  98682
ContactRonald L Lealos
CorrespondentRonald L Lealos
SALIVA DIAGNOSTIC SYSTEMS, INC. 11719 NE 95TH ST. Vancouver,  WA  98682
Product CodePJD  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-20
Decision Date1995-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840937103142 K942435 000
00840937105108 K942435 000
00840937105078 K942435 000

Trademark Results [SALIVA SAMPLER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SALIVA SAMPLER
SALIVA SAMPLER
75339949 2217993 Dead/Cancelled
Saliva Diagnostic Systems, Inc.
1997-08-12

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