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FDA 510(k)

CARDIOISOZYME, CK/LD ISOENZYME CONTROL

K-Number: K970856 · 1997-04-08

ApplicantMedical Analysis Systems, Inc.
Decision Date1997-04-08
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIOISOZYME, CK/LD ISOENZYME CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1997-04-08 under 510(k) number K970856. 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 CARDIOISOZYME, CK/LD ISOENZYME CONTROL?

CARDIOISOZYME, CK/LD ISOENZYME CONTROL is a medical device that received FDA 510(k) clearance on 1997-04-08. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K970856.

When did CARDIOISOZYME, CK/LD ISOENZYME CONTROL receive FDA 510(k) clearance?

CARDIOISOZYME, CK/LD ISOENZYME CONTROL received FDA 510(k) clearance on 1997-04-08, under 510(k) number K970856.

Who is the listed applicant for CARDIOISOZYME, CK/LD ISOENZYME CONTROL?

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

What is the FDA product code for CARDIOISOZYME, CK/LD ISOENZYME CONTROL?

The FDA product code for CARDIOISOZYME, CK/LD ISOENZYME CONTROL is JJT.

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Other records listing Medical Analysis Systems, 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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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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