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FDA 510(k)

SPECTRAL'S 2 IN 1 (TNI-MYO)

K-Number: K020950 · 2002-05-24

ApplicantSpectral Diagnostics, Inc.
Decision Date2002-05-24
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECTRAL'S 2 IN 1 (TNI-MYO) 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 2002-05-24 under 510(k) number K020950. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRAL'S 2 IN 1 (TNI-MYO)?

SPECTRAL'S 2 IN 1 (TNI-MYO) is a medical device that received FDA 510(k) clearance on 2002-05-24. The listed applicant is Spectral Diagnostics, Inc.. The 510(k) number is K020950.

When did SPECTRAL'S 2 IN 1 (TNI-MYO) receive FDA 510(k) clearance?

SPECTRAL'S 2 IN 1 (TNI-MYO) received FDA 510(k) clearance on 2002-05-24, under 510(k) number K020950.

Who is the listed applicant for SPECTRAL'S 2 IN 1 (TNI-MYO)?

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 2 IN 1 (TNI-MYO)?

The FDA product code for SPECTRAL'S 2 IN 1 (TNI-MYO) is MMI.

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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 TESTK014105SPECTRAL'S TROPONIN IK992127CARDIOQUANT TROPONIN I TESTK991447CARDIOQUANT CARDIAC ASSESSMENT CONTROLS

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Related Devices (Code: MMI)

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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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