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Document Number | K152551 |
Test Name | Zero Chaos, zerochaos Butalbital Drug Test Cup |
Manufacturer Name | W.H.P.M., INC. |
Consumer Information Phone Number | 1(877)937-6242 |
Test Type | Barbiturates |
Effective Date | 07/02/2019 |
| |
Device Classification Name |
Enzyme Immunoassay, Opiates
|
510(k) Number |
K152551 |
Device Name |
First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. |
Applicant |
W.H.P.M., INC. |
5358 IRWINDALE AVE. |
IRWINDALE,
CA
91706
|
|
Applicant Contact |
JOHN WAN |
Correspondent |
LSI |
504E DIAMOND AVE., SUITE I |
GAITHERSBURG,
MD
20877
|
|
Correspondent Contact |
JOE SHIA |
Regulation Number | 862.3650
|
Classification Product Code |
|
Subsequent Product Code |
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Date Received | 09/08/2015 |
Decision Date | 11/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
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