FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

DRUG STOP

K Number: K991465 · Decision Dec 10, 1999
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
17
Applicant Total
27
Review Days
227

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Basic Information

Device Name
DRUG STOP
K Number
K991465
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Texas Immunology, Inc.
Date Received
April 27, 1999
Decision Date
December 10, 1999
Product Code
MVO
Advisory Committee
Unknown
Review Advisory Committee
TX
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

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Other Clearances by Texas Immunology, Inc.

K Number Device Name
K980153 DRUG CHECK
K973208 FIRST SIGN
K972094 TARGET CARDIAC TROPONIN I TEST
K963680 TARGET MYOGLOBIN TEST
K912246 TARGET MICROALBUMINURIA TEST
K910073 TARGET ASO TEST
K904105 V-TREND TARGET RF TEST
K892231 V-TREND TARGET CRP TEST
K890423 V-TREND TARGET CRP TEST
K890041 V-TREND TARGET IM TEST
Search all 27 clearances from Texas Immunology, Inc. →