RA-1000 SYSTEM ADD'L ANALYTES PHASE III— 510(k) K820913

Name: FDA 510(k) clearance K820913
Creator: U.S. Food and Drug Administration
Published: 1982-05-03

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K820913 for RA-1000 SYSTEM ADD'L ANALYTES PHASE III, Substantially Equivalent on 1982-05-03. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1982-04-01
Decision date: 1982-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEK

view all

K992846 — HICHEM TOTAL PROTEIN REAGENT1999-10-18
K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-501998-03-02
K980042 — CARESIDE TOTAL PROTEIN1998-02-04
K971524 — TOTAL PROTEIN OR TP1997-05-16
K961864 — CSF/URINE TOTAL PROTEIN1996-10-24

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.