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510(k) K893125

BECKMAN EPSILON(TM) IGE REAGENT KIT by Beckman Instruments, Inc. — Product Code DGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
April 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
PA
Submission Type

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  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (March 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)

Other clearances for product code DGO

  • K943194 — IMMULITE(R) ALLERGY FOOD PANEL FP5E (February 23, 1995)
  • K920087 — IGE EIA TEST KIT (September 14, 1992)
  • K911511 — ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED (April 17, 1991)
  • K894039 — QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION (July 14, 1989)
  • K872801 — ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 (September 10, 1987)
  • K860851 — ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM (March 28, 1986)
  • K853607 — ALLERG-E IGE ENZYME IMMUNOASSAY KIT (November 7, 1985)
  • K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (November 21, 1983)
  • K831987 — EPSILON IGE TEST KIT (October 14, 1983)
  • K831774 — LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- (July 18, 1983)