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510(k) K831774

LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- by Diagnostic Reagent Tech. — Product Code DGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
June 2, 1983
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

Other clearances by Diagnostic Reagent Tech.

  • K843302 — NEW ALLERG. COATED MICROFILTER WELL STRI (October 4, 1984)
  • K832345 — POLYSTYRENE MICROTITER WELL IMMUNOSOR (November 25, 1983)
  • K832344 — POLYSTYRENE MICROTITER PLATE IMMUNO- (November 21, 1983)
  • K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (November 21, 1983)
  • K831496 — ALLERGEN IMMUNOSORBENTS IP SPECIFIC E (August 8, 1983)
  • K830005 — IP SPECIFIC G (June 2, 1983)
  • K830653 — POLYSTYRENE MICROTITER PLATE IMMUNOSORB (April 8, 1983)
  • K830495 — POLYSTYRENE MICROTITER PLATE IMMUNOSOR (April 5, 1983)
  • K821094 — IP SPECIFIC E (May 7, 1982)

Other clearances for product code DGO

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  • 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)
  • K893125 — BECKMAN EPSILON(TM) IGE REAGENT KIT (June 16, 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)