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510(k) K832717

DIAGNON B12 57CO RIA KIT by Diagnon Corp. — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
August 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

Other clearances by Diagnon Corp.

  • K860967 — VIRTRAN VIRAL TRANSPORTER (MODIFIED) (April 4, 1986)
  • 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)

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