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510(k) K853607

ALLERG-E IGE ENZYME IMMUNOASSAY KIT by Dexall Biomedical Labs, Inc. — Product Code DGO

K853607 is an FDA 510(k) premarket notification submitted by Dexall Biomedical Labs, Inc. for the device "ALLERG-E IGE ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on November 7, 1985. The device falls under product code DGO (Ige, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Dexall Biomedical Labs, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1985
Date Received
August 28, 1985
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 Dexall Biomedical Labs, Inc.

  • K885269 — ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS (February 7, 1989)
  • K875066 — ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT (January 29, 1988)
  • K864696 — ALLERG*ENS ENZYME IMMUNOASSAY KIT (March 17, 1987)

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)
  • 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)
  • 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)

FDA data resources