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FDA 510(k)

CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION

K-Number: K946146 · 1995-01-24

ApplicantClinical Controls, Inc.
Decision Date1995-01-24
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Controls, Inc.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K946146. 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 CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION?

CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K946146.

When did CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION receive FDA 510(k) clearance?

CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION received FDA 510(k) clearance on 1995-01-24, under 510(k) number K946146.

Who is the listed applicant for CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION?

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

What is the FDA product code for CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION?

The FDA product code for CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION is JJT.

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Other records listing Clinical Controls, Inc. 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.

K964278WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6K962432LIQUISPEX URINE (MICRO)ALBUMIN CONTROLK955691SERUM VOLATILES CONTROL LEVEL 1 & 2K955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2

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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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