FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCESS ULTRASENSITIVE INSULIN ASSAY
K Number: K953084
·
Decision Sep 25, 1995
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
82
Review Days
84
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Basic Information
- Device Name
- ACCESS ULTRASENSITIVE INSULIN ASSAY
- K Number
- K953084
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1405
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad Laboratories, Inc.
- Date Received
- July 3, 1995
- Decision Date
- September 25, 1995
- Product Code
- CFP
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CFP | Radioimmunoassay, Immunoreactive Insulin | FDA class 1 | Clinical Chemistry |
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