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FDA 510(k)

CARDIAC STATUS CONTROLS/TROPONIN I

K-Number: K972687 · 1997-07-28

ApplicantSpectral Diagnostics, Inc.
Decision Date1997-07-28
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIAC STATUS CONTROLS/TROPONIN I 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 1997-07-28 under 510(k) number K972687. 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 CARDIAC STATUS CONTROLS/TROPONIN I?

CARDIAC STATUS CONTROLS/TROPONIN I is a medical device that received FDA 510(k) clearance on 1997-07-28. The listed applicant is Spectral Diagnostics, Inc.. The 510(k) number is K972687.

When did CARDIAC STATUS CONTROLS/TROPONIN I receive FDA 510(k) clearance?

CARDIAC STATUS CONTROLS/TROPONIN I received FDA 510(k) clearance on 1997-07-28, under 510(k) number K972687.

Who is the listed applicant for CARDIAC STATUS CONTROLS/TROPONIN I?

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 CARDIAC STATUS CONTROLS/TROPONIN I?

The FDA product code for CARDIAC STATUS CONTROLS/TROPONIN I is JJX.

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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 TESTK022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTK020950SPECTRAL'S 2 IN 1 (TNI-MYO)K014105SPECTRAL'S TROPONIN IK992127CARDIOQUANT TROPONIN I TEST

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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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