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FDA 510(k)

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO

K-Number: K961412 · 1996-06-18

ApplicantBayer Corp.
Decision Date1996-06-18
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1996-06-18 under 510(k) number K961412. 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 CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO?

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO is a medical device that received FDA 510(k) clearance on 1996-06-18. The listed applicant is Bayer Corp.. The 510(k) number is K961412.

When did CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO receive FDA 510(k) clearance?

CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO received FDA 510(k) clearance on 1996-06-18, under 510(k) number K961412.

Who is the listed applicant for CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO?

The FDA product code for CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO is JHY.

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Other records listing Bayer Corp. 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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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 DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE 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.

Official Source

View on FDA Database →

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

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