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FDA 510(k)

CARDIOZYME CK-CONTROL LEVEL 1

K-Number: K771740 · 1977-10-19

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1977-10-19
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOZYME CK-CONTROL LEVEL 1 is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-10-19 under 510(k) number K771740. 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 CARDIOZYME CK-CONTROL LEVEL 1?

CARDIOZYME CK-CONTROL LEVEL 1 is a medical device that received FDA 510(k) clearance on 1977-10-19. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K771740.

When did CARDIOZYME CK-CONTROL LEVEL 1 receive FDA 510(k) clearance?

CARDIOZYME CK-CONTROL LEVEL 1 received FDA 510(k) clearance on 1977-10-19, under 510(k) number K771740.

Who is the listed applicant for CARDIOZYME CK-CONTROL LEVEL 1?

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

What is the FDA product code for CARDIOZYME CK-CONTROL LEVEL 1?

The FDA product code for CARDIOZYME CK-CONTROL LEVEL 1 is JJT.

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Other records listing Dade, Baxter Travenol 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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