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510(k) K841302

DIAGNON FOLATE 125I RIA KIT by Diagnon Corp. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1984
Date Received
March 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

Other clearances by Diagnon Corp.

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  • 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)
  • K832717 — DIAGNON B12 57CO RIA KIT (December 8, 1983)

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