FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA, T3 UPTAKE SOLID PHASE
K Number: K781662
·
Decision Nov 8, 1978
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
92
Applicant Total
632
Review Days
41
Basic Information
- Device Name
- RIA, T3 UPTAKE SOLID PHASE
- K Number
- K781662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- Date Received
- September 28, 1978
- Decision Date
- November 8, 1978
- Product Code
- KHQ
- 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 |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
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