RAPID SPECIFIC IGE PROCEDURE— 510(k) K863394

Substantially Equivalent

Allertec, Inc.

FDA 510(k) clearance K863394 for RAPID SPECIFIC IGE PROCEDURE, Substantially Equivalent on 1986-12-03. Applicant: Allertec, Inc.. Device class: 2.

Clearance details

Applicant: Allertec, Inc.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1986-09-03
Decision date: 1986-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHB

K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)2026-09-04
K261027 — NOVEOS Specific IgE (sIgE) +5 more2026-07-24
K260591 — NOVEOS Specific IgE (sIgE) +5 more2026-07-21
K260280 — NOVEOS Specific IgE (sIgE) +5 more2026-06-18
K260059 — NOVEOS Specific IgE (sIgE) +8 more2026-05-15

More clearances from Allertec, Inc.

K862368 — AMPLIFIED ELISA IGE KIT1986-07-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.