FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMIT-AMD AMIKACIN ASSAY
K Number: K822657
·
Decision Sep 28, 1982
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
19
Applicant Total
343
Review Days
25
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Basic Information
- Device Name
- EMIT-AMD AMIKACIN ASSAY
- K Number
- K822657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Dade Behring, Inc.
- Date Received
- September 3, 1982
- Decision Date
- September 28, 1982
- Product Code
- KLQ
- 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 |
|---|---|---|---|
| KLQ | Radioimmunoassay, Amikacin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLQ), ordered by most recent decision date.
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FDA Class 2
·Clinical Toxicology
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