Home / 510(k) Clearances / K884147

510(k) K884147

IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M by Orion Diagnostica, Inc. — Product Code DFT

K884147 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M". The FDA issued a decision of Substantially Equivalent on October 27, 1988. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1988
Date Received
October 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Orion Diagnostica, Inc.

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884040 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A (October 19, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

Other clearances for product code DFT

  • K983132 — IGM (November 4, 1998)
  • K962201 — QUANTEX IGM (September 25, 1996)
  • K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K901453 — QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD (April 12, 1990)
  • K894417 — RAICHEM(TM) SPIA(TM) IGM REAGENTS (August 2, 1989)
  • K880828 — WAKO(TM) IGM-HA DIRECT (March 25, 1988)
  • K873871 — IMMUNOGLOBULINS M (October 13, 1987)
  • K872237 — KALLESTAD QM300 IGM ANTIBODY PACK (July 9, 1987)
  • K871498 — TITAN GEL IMMUNOFIX CONTROLS (April 29, 1987)

FDA data resources