FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIRST SIGN DRUG OF ABUSE SCREENING TEST
K Number: K032575
·
Decision May 19, 2004
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
224
Applicant Total
14
Review Days
273
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Basic Information
- Device Name
- FIRST SIGN DRUG OF ABUSE SCREENING TEST
- K Number
- K032575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3100
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.H.P.M., Inc.
- Date Received
- August 20, 2003
- Decision Date
- May 19, 2004
- Product Code
- DKZ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | FDA class 2 | Clinical Toxicology |
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| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana | Feb 5, 2018 | Substantially Equivalent |
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| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | Feb 26, 2015 | Substantially Equivalent |
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| K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | Jun 9, 2006 | Substantially Equivalent |
| K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | Aug 22, 2005 | Substantially Equivalent |