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510(k) K780148

RIA FOR FOLATES & VIT. B12, COMBO KIT by Ria Products, Inc. — Product Code CGN

K780148 is an FDA 510(k) premarket notification submitted by Ria Products, Inc. for the device "RIA FOR FOLATES & VIT. B12, COMBO KIT". The FDA issued a decision of Substantially Equivalent on March 3, 1978. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Ria Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1978
Date Received
January 30, 1978
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 Ria Products, Inc.

  • K813310 — NO-HOIL COMBOSTAT II KIT (December 17, 1981)
  • K802969 — CORTISOL 125-I RADIOIMMUNOASSAY KIT (January 2, 1981)
  • K801578 — COMBOSTAT - NO-BOIL KIT (October 23, 1980)
  • K801579 — VITAMIN B12 - NO-BOIL KIT (October 23, 1980)
  • K800710 — FERRITIRON KIT CAT. #RP-1100 (May 14, 1980)
  • K800914 — NO-BOIL FOLATE KIT #RP-500 (May 8, 1980)
  • K781844 — FERRITIN KIT (January 10, 1979)
  • K781769 — IRON 59 KIT (December 4, 1978)

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