FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K Number: K991084
·
Decision Apr 15, 1999
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
99
Applicant Total
72
Review Days
20
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Basic Information
- Device Name
- ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
- K Number
- K991084
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- March 26, 1999
- Decision Date
- April 15, 1999
- Product Code
- DIS
- 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 |
|---|---|---|---|
| DIS | Enzyme Immunoassay, Barbiturate | FDA class 2 | Clinical Toxicology |
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