FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA KIT, VITAMIN B12
K Number: K782024
·
Decision Feb 28, 1979
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
9
Review Days
85
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Basic Information
- Device Name
- RIA KIT, VITAMIN B12
- K Number
- K782024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technia Diagnostics , Ltd.
- Date Received
- December 5, 1978
- Decision Date
- February 28, 1979
- Product Code
- CDD
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | FDA class 2 | Clinical Chemistry |
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Other Clearances by Technia Diagnostics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K861978 | AUTOFLUOR V | Jun 10, 1986 | Substantially Equivalent |
| K801843 | T3(125) RADIOIMMUNOASSAY KIT | Sep 16, 1980 | Substantially Equivalent |
| K801202 | DIGOXIN RADIOIMMUNOASSAY KIT | Jun 20, 1980 | Substantially Equivalent |
| K801203 | CORTISOL RADIOIMMUNOASSAY KIT | Jun 9, 1980 | Substantially Equivalent |
| K791361 | T3 UPTAKE RADIOIMMUNOASSAY KIT | Aug 16, 1979 | Substantially Equivalent |
| K790919 | HPL RIA KIT | Jun 28, 1979 | Substantially Equivalent |
| K790495 | THYROXINE RIA KIT | May 3, 1979 | Substantially Equivalent |
| K782025 | GENTAMICIN FLUROIMMUNASSAY KIT | Jan 26, 1979 | Substantially Equivalent |