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510(k) K831103

TIA-IGM REAGENT & CALIBRATOR SETS by Worthington Diagnostic Systems — Product Code DFT

K831103 is an FDA 510(k) premarket notification submitted by Worthington Diagnostic Systems for the device "TIA-IGM REAGENT & CALIBRATOR SETS". The FDA issued a decision of Substantially Equivalent on April 27, 1983. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Worthington Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1983
Date Received
April 5, 1983
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 Worthington Diagnostic Systems

  • K833708 — COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (January 4, 1984)
  • K832427 — EASYTOUCH TROMBOPLASTIN REAGENT (October 14, 1983)
  • K832748 — COMPUR* EASYTOUCH TOTAL BILIRUBIN (October 14, 1983)
  • K832749 — EASYTOUCH BUN REAGENT SET (October 14, 1983)
  • K832785 — COMPUR* EASY TOUCH URIC ACID REAGENT (October 14, 1983)
  • K832750 — EASYTOUCH HEMOGLOBIN REAGENT (September 26, 1983)
  • K832426 — EASYTOUCH TRIGLYCERIDES REAGENT SET (September 12, 1983)
  • K831477 — DEMAND ANALYZER SYSTEM (June 17, 1983)
  • K831318 — COMPUR* M1100 HEMATRCRIT SYSTEM (June 8, 1983)
  • K831227 — COMPUR EASY TOUCH CHEMISTRY ANALYZER- (June 2, 1983)

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)
  • 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)

FDA data resources