TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY— 510(k) K884085

Name: FDA 510(k) clearance K884085
Creator: U.S. Food and Drug Administration
Published: 1988-12-02

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K884085 for TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1988-12-02. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1988-09-27
Decision date: 1988-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHY

view all

K143720 — Dimension Vista MMB Assay2015-09-18
K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL2014-05-13
K140404 — ELECSYS CK-MB STAT IMMUNOASSAY2014-05-08
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY2013-10-18
K070835 — OLYMPUS CK-MB REAGENT2007-06-04

More clearances from Hybritech, Inc.

view all

K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY1997-09-11
K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY1996-08-19
K930810 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY1994-01-11
K922754 — TANDEM-E IGE II CALIBRATION VERIFICATION SET1993-02-17
K921745 — HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO1992-07-30

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