COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM— 510(k) K882621

Name: FDA 510(k) clearance K882621
Creator: U.S. Food and Drug Administration
Published: 1988-07-08

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K882621 for COMPLEMENT C4 FOR THE 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 DBI
Device class: Class 2
Regulation: 21 CFR 866.5240
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 DBI

view all

K100455 — SPAPLUS ANALYZER2010-09-03
K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM2001-11-29
K010325 — WAKO AUTOKIT C42001-06-25
K000468 — RANDOX COMPLEMENT C42000-03-27
K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE2000-03-01

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.