FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOFLUOR V
K Number: K861978
·
Decision Jun 10, 1986
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
18
Applicant Total
9
Review Days
20
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Basic Information
- Device Name
- AUTOFLUOR V
- K Number
- K861978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Technia Diagnostics , Ltd.
- Date Received
- May 21, 1986
- Decision Date
- June 10, 1986
- Product Code
- KTL
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | FDA class 2 | Immunology |
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Other Clearances by Technia Diagnostics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K782024 | RIA KIT, VITAMIN B12 | Feb 28, 1979 | Substantially Equivalent |
| K782025 | GENTAMICIN FLUROIMMUNASSAY KIT | Jan 26, 1979 | Substantially Equivalent |