ANALYZER, GLUCOSE/UREA/CREATININE— 510(k) K760211

Name: FDA 510(k) clearance K760211
Creator: U.S. Food and Drug Administration
Published: 1976-08-26

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K760211 for ANALYZER, GLUCOSE/UREA/CREATININE, Substantially Equivalent on 1976-08-26. Applicant: Instrumentation Laboratory CO. Device class: 1.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code JJC
Device class: Class 1
Regulation: 21 CFR 862.2150
Advisory panel: Clinical Chemistry
Date received: 1976-07-12
Decision date: 1976-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJC

view all

K945915 — AVL OMNI ANALYZER1995-04-05
K945584 — NOVA 16 ANALYZER1995-02-08
K943376 — OPERA SYSTEM1994-09-14
K901410 — TECHNICON RA-2000(TM) SYSTEM1990-07-17
K901141 — PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX1990-04-09

More clearances from Instrumentation Laboratory CO

view all

K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM2023-09-29
K223187 — HemosIL Liquid Anti-Xa2023-06-23
K223090 — GEM Premier ChemSTAT2023-01-27
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09
K213464 — HemosIL Liquid Anti-Xa2022-10-04

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