FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GLUCAGON RIA MODULE
K Number: K771948
·
Decision Jan 20, 1978
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
2
Applicant Total
3
Review Days
95
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Basic Information
- Device Name
- GLUCAGON RIA MODULE
- K Number
- K771948
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1335
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Inter Science Institute
- Date Received
- October 17, 1977
- Decision Date
- January 20, 1978
- Product Code
- JME
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JME | Radioimmunoassay, Glucagon | FDA class 1 | Clinical Chemistry |
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