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510(k) K945522

I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS by Beckman-Diagnostic Systems Group — Product Code DFT

K945522 is an FDA 510(k) premarket notification submitted by Beckman-Diagnostic Systems Group for the device "I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS". The FDA issued a decision of Substantially Equivalent on December 12, 1994. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Beckman-Diagnostic Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1994
Date Received
November 10, 1994
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 Beckman-Diagnostic Systems Group

  • K944605 — CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM (December 7, 1994)
  • K944604 — CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS (December 7, 1994)
  • K944606 — CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS (November 30, 1994)
  • K942676 — SYNCHRON CX3 DELTA (November 2, 1994)
  • K934293 — BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT (July 6, 1994)
  • K934068 — BECKMAN DIRECT BILIRUBIN REAGENT (April 26, 1994)
  • K936184 — VIGIL PRX CHEMISTRY CONTROL (April 15, 1994)
  • K934271 — BECKMAN SYNCHRON LACTATE REAGENT (November 9, 1993)
  • K934046 — BECKMAN CHOLESTEROL REAGENT (October 28, 1993)
  • K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL (October 27, 1993)

Other clearances for product code DFT

  • K983132 — IGM (November 4, 1998)
  • K962201 — QUANTEX IGM (September 25, 1996)
  • K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • 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