IL TEST DAT CAL/CONTROL SET D/E— 510(k) K920419

Name: FDA 510(k) clearance K920419
Creator: U.S. Food and Drug Administration
Published: 1992-03-11

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K920419 for IL TEST DAT CAL/CONTROL SET D/E, Substantially Equivalent on 1992-03-11. Applicant: Instrumentation Laboratory CO. Device class: 1.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code DLG
Device class: Class 1
Regulation: 21 CFR 862.2250
Advisory panel: Clinical Chemistry
Date received: 1992-01-31
Decision date: 1992-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DLG

view all

K050988 — OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS2006-04-06
K894518 — FPR AMIKACIN CALIBRATOR KIT1989-09-28
K894524 — FPR GENTAMICIN CALIBRATOR KIT1989-09-28
K894528 — FPR PHENYTOIN CALIBRATOR KIT1989-09-25
K882766 — EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/951988-08-23

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.