IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)— 510(k) K890609

Name: FDA 510(k) clearance K890609
Creator: U.S. Food and Drug Administration
Published: 1989-03-16

Substantially Equivalent

Intl. Immunoassay Laboratories, Inc.

FDA 510(k) clearance K890609 for IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE), Substantially Equivalent on 1989-03-16. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Immunoassay Laboratories, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1989-02-07
Decision date: 1989-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGS

view all

K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set2020-08-11
K182702 — SEKURE Creatine Kinase Assay2019-04-17
K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator2016-09-07
K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR2013-11-21
K112416 — CPK REAGENT2011-11-09

More clearances from Intl. Immunoassay Laboratories, Inc.

view all

K913380 — MYDAS(TM)-MB2/MYDAS(TM)-MB1992-04-22
K913349 — STAMBI-CK1991-10-23
K912231 — PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT1991-07-08
K903441 — MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS1990-11-06
K903508 — LABELLING CHANGES TO IMPRES-MB-X1990-09-07

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