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510(k) K800914

NO-BOIL FOLATE KIT #RP-500 by Ria Products, Inc. — Product Code CGN

K800914 is an FDA 510(k) premarket notification submitted by Ria Products, Inc. for the device "NO-BOIL FOLATE KIT #RP-500". The FDA issued a decision of Substantially Equivalent on May 8, 1980. 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
May 8, 1980
Date Received
April 21, 1980
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)
  • K801579 — VITAMIN B12 - NO-BOIL KIT (October 23, 1980)
  • K801578 — COMBOSTAT - NO-BOIL KIT (October 23, 1980)
  • K800710 — FERRITIRON KIT CAT. #RP-1100 (May 14, 1980)
  • K781844 — FERRITIN KIT (January 10, 1979)
  • K781769 — IRON 59 KIT (December 4, 1978)
  • K780148 — RIA FOR FOLATES & VIT. B12, COMBO KIT (March 3, 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