FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
K Number: K821950
·
Decision Jul 20, 1982
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
206
Review Days
20
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Basic Information
- Device Name
- Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
- K Number
- K821950
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Travenol Laboratories, S.A.
- Date Received
- June 30, 1982
- Decision Date
- July 20, 1982
- Product Code
- DIF
- Advisory Committee
- Clinical Toxicology
- 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 | Device Class | Medical Specialty |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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FDA 510(k)
FDA Class 1
·Clinical Toxicology
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