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FDA 510(k)

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

K-Number: K022409 · 2002-09-30

ApplicantSpectral Diagnostics, Inc.
Decision Date2002-09-30
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-09-30 under 510(k) number K022409. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST?

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST is a medical device that received FDA 510(k) clearance on 2002-09-30. The listed applicant is Spectral Diagnostics, Inc.. The 510(k) number is K022409.

When did SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST receive FDA 510(k) clearance?

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST received FDA 510(k) clearance on 2002-09-30, under 510(k) number K022409.

Who is the listed applicant for SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST?

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

What is the FDA product code for SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST?

The FDA product code for SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST is JHT.

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Other records listing Spectral Diagnostics, 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.

K052519SPECTRAL WEST NILE VIRUS IGM STATUS TESTK030057SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TESTK020950SPECTRAL'S 2 IN 1 (TNI-MYO)K014105SPECTRAL'S TROPONIN IK992127CARDIOQUANT TROPONIN I TESTK991447CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

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Related Devices (Code: JHT)

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.

K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena LaboratoriesK904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, Inc.K896170REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083Helena Laboratories

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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