FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOXI*LAB LTD OPIATE SYSTEM
K Number: K932209
·
Decision Sep 24, 1993
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
141
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Basic Information
- Device Name
- TOXI*LAB LTD OPIATE SYSTEM
- K Number
- K932209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Toxi-Lab, Inc.
- Date Received
- May 6, 1993
- Decision Date
- September 24, 1993
- Product Code
- LAI
- 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 |
|---|---|---|---|
| LAI | Thin Layer Chromatography, Opiates | FDA class 2 | Clinical Toxicology |