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510(k) K860851

ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM by Nichols Institute Diagnostics — Product Code DGO

K860851 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 28, 1986. The device falls under product code DGO (Ige, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 28, 1986
Date Received
Mar 7, 1986
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 Nichols Institute Diagnostics

  • K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (Jun 1, 2005)
  • K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY (Dec 17, 2004)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (Dec 9, 2004)
  • K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 (Jun 8, 2004)
  • K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY (Apr 22, 2004)
  • K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (Jan 26, 2004)
  • K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (Jul 31, 2003)
  • K022356 — NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASS (Oct 25, 2002)
  • K022472 — PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTAC (Oct 9, 2002)
  • K013992 — NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNO (Dec 13, 2001)

Other clearances for product code DGO

  • K943194 — IMMULITE(R) ALLERGY FOOD PANEL FP5E (Feb 23, 1995)
  • K920087 — IGE EIA TEST KIT (Sep 14, 1992)
  • K911511 — ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED (Apr 17, 1991)
  • K894039 — QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION (Jul 14, 1989)
  • K893125 — BECKMAN EPSILON(TM) IGE REAGENT KIT (Jun 16, 1989)
  • K872801 — ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 (Sep 10, 1987)
  • K853607 — ALLERG-E IGE ENZYME IMMUNOASSAY KIT (Nov 7, 1985)
  • K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (Nov 21, 1983)
  • K831987 — EPSILON IGE TEST KIT (Oct 14, 1983)
  • K831774 — LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- (Jul 18, 1983)

FDA data resources