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
LIO Device, Specimen Collection

Similar 510(k) Clearances

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Other Clearances by Diagnon Corp.

K Number Device Name
K860967 VIRTRAN VIRAL TRANSPORTER (MODIFIED)
K851635 DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
K851377 DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
K841302 DIAGNON FOLATE 125I RIA KIT
K832717 DIAGNON B12 57CO RIA KIT