FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GASTRIN RIA DIAGNOSTIC KIT
K Number: K812004
·
Decision Jul 28, 1981
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
883
Review Days
14
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Basic Information
- Device Name
- GASTRIN RIA DIAGNOSTIC KIT
- K Number
- K812004
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1325
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- July 14, 1981
- Decision Date
- July 28, 1981
- Product Code
- CGC
- 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 |
|---|---|---|---|
| CGC | Radioimmunoassay, Gastrin | FDA class 1 | Clinical Chemistry |
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