STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK— 510(k) K981099

Name: FDA 510(k) clearance K981099
Creator: U.S. Food and Drug Administration
Published: 1998-05-26

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K981099 for STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK, Substantially Equivalent on 1998-05-26. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code JHX
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1998-03-26
Decision date: 1998-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHX

view all

K234005 — Access CK-MB2024-02-16
K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack2022-01-28
K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX2017-09-21
K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE2012-11-21
K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II2009-08-17

More clearances from Dade Behring, Inc.

view all

K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT072010-12-20
K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST2008-07-28
K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM2008-07-21
K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)2008-06-25
K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC6002008-06-04

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