FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIRTRAN VIRAL TRANPORTER
K Number: K851378
·
Decision Jun 21, 1985
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
6
Review Days
74
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Basic Information
- Device Name
- VIRTRAN VIRAL TRANPORTER
- K Number
- K851378
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Diagnon Corp.
- Date Received
- April 8, 1985
- Decision Date
- June 21, 1985
- Product Code
- LIO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | FDA class 1 | Microbiology |
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Other Clearances by Diagnon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K860967 | VIRTRAN VIRAL TRANSPORTER (MODIFIED) | Apr 4, 1986 | Substantially Equivalent |
| K851635 | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST | Oct 10, 1985 | Substantially Equivalent |
| K851377 | DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA | Aug 21, 1985 | Substantially Equivalent |
| K841302 | DIAGNON FOLATE 125I RIA KIT | Jun 22, 1984 | Substantially Equivalent |
| K832717 | DIAGNON B12 57CO RIA KIT | Dec 8, 1983 | Substantially Equivalent |