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FDA 510(k)

DADE(R) CK-MB IMMUNOASSAY CONTROL

K-Number: K882795 · 1988-08-29

ApplicantBaxter Healthcare Corp
Decision Date1988-08-29
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DADE(R) CK-MB IMMUNOASSAY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-08-29 under 510(k) number K882795. 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 DADE(R) CK-MB IMMUNOASSAY CONTROL?

DADE(R) CK-MB IMMUNOASSAY CONTROL is a medical device that received FDA 510(k) clearance on 1988-08-29. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K882795.

When did DADE(R) CK-MB IMMUNOASSAY CONTROL receive FDA 510(k) clearance?

DADE(R) CK-MB IMMUNOASSAY CONTROL received FDA 510(k) clearance on 1988-08-29, under 510(k) number K882795.

Who is the listed applicant for DADE(R) CK-MB IMMUNOASSAY CONTROL?

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

What is the FDA product code for DADE(R) CK-MB IMMUNOASSAY CONTROL?

The FDA product code for DADE(R) CK-MB IMMUNOASSAY CONTROL is JJT.

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Other records listing Baxter Healthcare Corp 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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