FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIOASSY KIT, 3H-FOLATE
K Number: K760262
·
Decision Aug 3, 1976
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
63
Applicant Total
2
Review Days
13
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Basic Information
- Device Name
- RADIOASSY KIT, 3H-FOLATE
- K Number
- K760262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1295
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diamond Shamrock Corp.
- Date Received
- July 21, 1976
- Decision Date
- August 3, 1976
- Product Code
- CGN
- 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 |
|---|---|---|---|
| CGN | Acid, Folic, Radioimmunoassay | FDA class 2 | Clinical Chemistry |
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Other Clearances by Diamond Shamrock Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K830197 | TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS | Nov 29, 1983 | Substantially Equivalent |