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FDA 510(k)

CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL

K-Number: K946145 · 1995-01-24

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

Device Summary

CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL 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 K946145. 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) CKMB/LD-1 IMMUNOINHIBITION CONTROL?

CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL 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 K946145.

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

CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL received FDA 510(k) clearance on 1995-01-24, under 510(k) number K946145.

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

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) CKMB/LD-1 IMMUNOINHIBITION CONTROL?

The FDA product code for CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL 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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