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FDA 510(k)

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/

K-Number: K850907 · 1985-06-25

ApplicantCala Diagnostics
Decision Date1985-06-25
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ is the device name listed in this FDA 510(k) record. The listed applicant is Cala Diagnostics. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K850907. 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 CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/?

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Cala Diagnostics. The 510(k) number is K850907.

When did CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ receive FDA 510(k) clearance?

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ received FDA 510(k) clearance on 1985-06-25, under 510(k) number K850907.

Who is the listed applicant for CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/?

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

What is the FDA product code for CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/?

The FDA product code for CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ is JJT.

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Other records listing Cala Diagnostics 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.

K944247CARDIOCHEX CKMB IMMUNOINHIBITION CONTROLK944246CARDIOCHEX CKMB MASS MEASUREMENT CONTROLK944243CARDIOCHEXK930874LD-1 CONTROL-LEVEL 1 & 2K930875CKMB CONTROL - LEVEL 1,2,3K930873CKMB ISOENZYME CONTROL-LEVEL 1,2.3

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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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