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FDA 510(k)

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3

K-Number: K926015 · 1992-12-28

ApplicantCala Diagnostics
Decision Date1992-12-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 is the device name listed in this FDA 510(k) record. The listed applicant is Cala Diagnostics. It received FDA 510(k) clearance on 1992-12-28 under 510(k) number K926015. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3?

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 is a medical device that received FDA 510(k) clearance on 1992-12-28. The listed applicant is Cala Diagnostics. The 510(k) number is K926015.

When did CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 receive FDA 510(k) clearance?

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 received FDA 510(k) clearance on 1992-12-28, under 510(k) number K926015.

Who is the listed applicant for CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3?

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 CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3?

The FDA product code for CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 is JJX.

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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: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.

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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