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510(k) K860967

VIRTRAN VIRAL TRANSPORTER (MODIFIED) by Diagnon Corp. — Product Code JSN

K860967 is an FDA 510(k) premarket notification submitted by Diagnon Corp. for the device "VIRTRAN VIRAL TRANSPORTER (MODIFIED)". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Diagnon Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1986
Date Received
March 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

Other clearances by Diagnon Corp.

  • K851635 — DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST (October 10, 1985)
  • K851377 — DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA (August 21, 1985)
  • K851378 — VIRTRAN VIRAL TRANPORTER (June 21, 1985)
  • K841302 — DIAGNON FOLATE 125I RIA KIT (June 22, 1984)
  • K832717 — DIAGNON B12 57CO RIA KIT (December 8, 1983)

Other clearances for product code JSN

  • K000718 — CHROMOSTREAK (August 24, 2000)
  • K962745 — ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (October 2, 1996)
  • K961755 — CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (May 17, 1996)
  • K961756 — CYTOQUANT VIRAL TRANSPORT MEDIUM (May 17, 1996)
  • K896296 — INPOUCH-TV POUCH (January 29, 1990)
  • K881579 — AMIES TRANSPORT MEDIUM W/O CHARCOAL (April 18, 1988)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K833968 — 10B (December 30, 1983)
  • K834065 — A3B (December 27, 1983)
  • K831186 — RAPID NFT (May 9, 1983)

FDA data resources