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FDA 510(k)

CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET

K-Number: K062593 · 2006-11-22

ApplicantCompass Bioscience
Decision Date2006-11-22
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Compass Bioscience. It received FDA 510(k) clearance on 2006-11-22 under 510(k) number K062593. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET?

CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Compass Bioscience. The 510(k) number is K062593.

When did CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET receive FDA 510(k) clearance?

CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET received FDA 510(k) clearance on 2006-11-22, under 510(k) number K062593.

Who is the listed applicant for CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET?

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

What is the FDA product code for CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET?

The FDA product code for CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET is JJY.

Related Clinical Trials

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.

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Other records listing Compass Bioscience 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.

K060570HEMOGLOBIN ALC CONTROL

Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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