FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K Number: K944562
·
Decision Nov 2, 1994
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
149
Applicant Total
107
Review Days
64
Basic Information
- Device Name
- MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
- K Number
- K944562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3870
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MICROGENICS CORP.
- Date Received
- August 30, 1994
- Decision Date
- November 2, 1994
- Product Code
- LDJ
- 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 |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | FDA class 2 | Clinical Toxicology |
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