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510(k) K781844

FERRITIN KIT by Ria Products, Inc. — Product Code JMG

K781844 is an FDA 510(k) premarket notification submitted by Ria Products, Inc. for the device "FERRITIN KIT". The FDA issued a decision of Substantially Equivalent on January 10, 1979. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Ria Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1979
Date Received
November 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device Class
Class II
Regulation Number
866.5340
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)
  • K781769 — IRON 59 KIT (December 4, 1978)
  • K780148 — RIA FOR FOLATES & VIT. B12, COMBO KIT (March 3, 1978)

Other clearances for product code JMG

  • K234052 — Access Ferritin (March 20, 2024)
  • K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (August 19, 2005)
  • K964282 — TINA-QUANT FERRITIN ASSAY (July 30, 1997)
  • K971833 — ELECSYS FERRITIN (June 2, 1997)
  • K963498 — FERR FLEX REAGENT CARTRIDGE (January 24, 1997)
  • K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAY (May 16, 1995)
  • K926221 — ACCESS FERRITIN ASSAY (January 13, 1993)
  • K925848 — IMMULITE FERRITIN (January 13, 1993)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)

FDA data resources