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510(k) K851377

DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA by Diagnon Corp. — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
April 8, 1985
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)
  • 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)

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