PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM— 510(k) K882623

Name: FDA 510(k) clearance K882623
Creator: U.S. Food and Drug Administration
Published: 1988-07-08

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K882623 for PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM, Substantially Equivalent on 1988-07-08. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code JZH
Device class: Class 2
Regulation: 21 CFR 866.5320
Advisory panel: Immunology
Date received: 1988-06-24
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZH

view all

K964843 — IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT1997-03-06
K831959 — RADIAL IMMUNO-TEST FOR HUMAN FACTOR B1983-07-19
K811740 — KALLESTAD'S ENDOPLATE FACTOR B TEST1981-07-16
K781016 — C3PA (GBG) PROPERDIN FACTOR B1978-08-14
K772084 — LAS-R HUMAN C3 PROACTIVATOR TEST1978-01-24

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.