FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
K Number: K002974
·
Decision Oct 11, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
343
Review Days
55
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Basic Information
- Device Name
- EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL
- K Number
- K002974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- August 17, 2000
- Decision Date
- October 11, 2000
- Product Code
- LDP
- 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 |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
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