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FDA 510(k)

OLYMPUS CK-MB REAGENT

K-Number: K070835 · 2007-06-04

ApplicantOlympus Life & Material Science Europa GmbH (Irish
Decision Date2007-06-04
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CK-MB REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Life & Material Science Europa GmbH (Irish. It received FDA 510(k) clearance on 2007-06-04 under 510(k) number K070835. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS CK-MB REAGENT?

OLYMPUS CK-MB REAGENT is a medical device that received FDA 510(k) clearance on 2007-06-04. The listed applicant is Olympus Life & Material Science Europa GmbH (Irish. The 510(k) number is K070835.

When did OLYMPUS CK-MB REAGENT receive FDA 510(k) clearance?

OLYMPUS CK-MB REAGENT received FDA 510(k) clearance on 2007-06-04, under 510(k) number K070835.

Who is the listed applicant for OLYMPUS CK-MB REAGENT?

The FDA 510(k) record lists Olympus Life & Material Science Europa GmbH (Irish as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS CK-MB REAGENT?

The FDA product code for OLYMPUS CK-MB REAGENT is JHY.

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Other records listing Olympus Life & Material Science Europa GmbH (Irish as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070708OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104K070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL

Related Devices (Code: JHY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, Inc.K961412CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITROBayer Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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