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FDA 510(k)

CANTROL CK/MB CONTROL

K-Number: K855006 · 1986-01-17

ApplicantCanyon Diagnostics, Inc.
Decision Date1986-01-17
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CANTROL CK/MB CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-01-17 under 510(k) number K855006. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANTROL CK/MB CONTROL?

CANTROL CK/MB CONTROL is a medical device that received FDA 510(k) clearance on 1986-01-17. The listed applicant is Canyon Diagnostics, Inc.. The 510(k) number is K855006.

When did CANTROL CK/MB CONTROL receive FDA 510(k) clearance?

CANTROL CK/MB CONTROL received FDA 510(k) clearance on 1986-01-17, under 510(k) number K855006.

Who is the listed applicant for CANTROL CK/MB CONTROL?

The FDA 510(k) record lists Canyon Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANTROL CK/MB CONTROL?

The FDA product code for CANTROL CK/MB CONTROL is JJT.

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Other records listing Canyon Diagnostics, Inc. as applicant

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Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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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