FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIRTRAN VIRAL TRANSPORTER (MODIFIED)
K Number: K860967
·
Decision Apr 4, 1986
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
12
Applicant Total
6
Review Days
25
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Basic Information
- Device Name
- VIRTRAN VIRAL TRANSPORTER (MODIFIED)
- K Number
- K860967
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Diagnon Corp.
- Date Received
- March 10, 1986
- Decision Date
- April 4, 1986
- Product Code
- JSN
- 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 |
|---|---|---|---|
| JSN | Culture Media, Propagating Transport | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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AMIES TRANSPORT MEDIUM W/O CHARCOAL
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Other Clearances by Diagnon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K851378 | VIRTRAN VIRAL TRANPORTER | Jun 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 |