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510(k) K983132

IGM by Abbott Laboratories — Product Code DFT

K983132 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "IGM". The FDA issued a decision of Substantially Equivalent on November 4, 1998. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1998
Date Received
September 8, 1998
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

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Other clearances for product code DFT

  • 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)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • 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