TECHNICON DPA-1 IMMUNOGLOBULIN G— 510(k) K883494

Name: FDA 510(k) clearance K883494
Creator: U.S. Food and Drug Administration
Published: 1988-09-07

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K883494 for TECHNICON DPA-1 IMMUNOGLOBULIN G, Substantially Equivalent on 1988-09-07. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code DAH
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1988-08-16
Decision date: 1988-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAH

view all

K931247 — TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 30671993-04-27
K905149 — TITAN GEL1991-01-03
K901805 — REP(R) IMMUNOFIX1990-06-06
K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G1988-10-27
K854944 — TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT1986-08-27

More clearances from Technicon Instruments Corp.

view all

K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL1991-11-27
K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST)1991-11-27
K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)1991-11-22
K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES1991-09-25
K912413 — CHEM-LINK DATA BASE MANAGER1991-07-01

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