POLYSTYRENE MICROTITER PLATE IMMUNOSORB— 510(k) K830653

Name: FDA 510(k) clearance K830653
Creator: U.S. Food and Drug Administration
Published: 1983-04-08

Substantially Equivalent

Diagnostic Reagent Tech.

FDA 510(k) clearance K830653 for POLYSTYRENE MICROTITER PLATE IMMUNOSORB, Substantially Equivalent on 1983-04-08. Applicant: Diagnostic Reagent Tech.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagent Tech.
Product code: Code DGO
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1983-03-01
Decision date: 1983-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DGO

view all

K943194 — IMMULITE(R) ALLERGY FOOD PANEL FP5E1995-02-23
K920087 — IGE EIA TEST KIT1992-09-14
K911511 — ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED1991-04-17
K894039 — QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION1989-07-14
K893125 — BECKMAN EPSILON(TM) IGE REAGENT KIT1989-06-16

More clearances from Diagnostic Reagent Tech.

view all

K843302 — NEW ALLERG. COATED MICROFILTER WELL STRI1984-10-04
K832345 — POLYSTYRENE MICROTITER WELL IMMUNOSOR1983-11-25
K831984 — POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE1983-11-21
K832344 — POLYSTYRENE MICROTITER PLATE IMMUNO-1983-11-21
K831496 — ALLERGEN IMMUNOSORBENTS IP SPECIFIC E1983-08-08

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