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FDA 510(k)

TRACE COBAS MIRA RANGE

K-Number: K952488 · 1995-10-13

ApplicantTrace Scientific , Ltd.
Decision Date1995-10-13
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACE COBAS MIRA RANGE is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K952488. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACE COBAS MIRA RANGE?

TRACE COBAS MIRA RANGE is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K952488.

When did TRACE COBAS MIRA RANGE receive FDA 510(k) clearance?

TRACE COBAS MIRA RANGE received FDA 510(k) clearance on 1995-10-13, under 510(k) number K952488.

Who is the listed applicant for TRACE COBAS MIRA RANGE?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACE COBAS MIRA RANGE?

The FDA product code for TRACE COBAS MIRA RANGE is CIX.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK932713TRACE TRANSFERRIN REAGENT

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Related Devices (Code: CIX)

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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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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