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510(k) K782157

IRMA TEST, NORDICLAB FERRITIN by Nordiclab Intl. — Product Code JMG

K782157 is an FDA 510(k) premarket notification submitted by Nordiclab Intl. for the device "IRMA TEST, NORDICLAB FERRITIN". The FDA issued a decision of Substantially Equivalent on January 17, 1979. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Nordiclab Intl. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1979
Date Received
December 22, 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 Nordiclab Intl.

  • K801988 — NORDICLAB PROSTATIC ACID PHOSPHATASE RIA (September 26, 1980)
  • K801989 — NORDICLAB FERRITIN IRMA TEST (September 16, 1980)
  • K800921 — NORDICLAB TESTOSTERONE RIA TEST (May 14, 1980)
  • K800920 — NORDICLAB ESTRADIOL RIA TEST (May 14, 1980)
  • K800922 — NORDICLAB PROGESTERONE RIA TEST (May 14, 1980)
  • K792189 — NORDICLAB TOTAL ESTRIOL RIA TEST (November 13, 1979)
  • K782099 — RIA TEST, NORDICALB HPL (January 10, 1979)

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)
  • K925848 — IMMULITE FERRITIN (January 13, 1993)
  • K926221 — ACCESS FERRITIN ASSAY (January 13, 1993)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)

FDA data resources