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510(k) K841302

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

K841302 is an FDA 510(k) premarket notification submitted by Diagnon Corp. for the device "DIAGNON FOLATE 125I RIA KIT". The FDA issued a decision of Substantially Equivalent on June 22, 1984. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Diagnon Corp. has at least 5 other 510(k) clearances on record.

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.

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

Other clearances for product code CGN

  • K233060 — Elecsys Folate III (June 17, 2024)
  • K223590 — Access Folate Assay (August 23, 2023)
  • K192586 — LIAISON® Folate (May 6, 2020)
  • K172201 — Atellica IM Folate Assay (April 12, 2018)
  • K161646 — Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (November 4, 2016)
  • K141426 — ELECSYS FOLATE III (October 17, 2014)
  • K103716 — ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET (May 12, 2011)
  • K092740 — ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CO (March 5, 2010)
  • K091332 — AIA-PACK RBC FOLATE (October 2, 2009)
  • K082340 — ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELE (June 19, 2009)

FDA data resources