FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K Number: K945608
·
Decision Feb 10, 1995
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
209
Applicant Total
70
Review Days
87
Basic Information
- Device Name
- ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
- K Number
- K945608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PRINCETON BIOMEDITECH CORP.
- Date Received
- November 15, 1994
- Decision Date
- February 10, 1995
- Product Code
- DJG
- 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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