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FDA 510(k)

THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609

K-Number: K012878 · 2001-10-16

ApplicantThermo Dma, Inc.
Decision Date2001-10-16
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Dma, Inc.. It received FDA 510(k) clearance on 2001-10-16 under 510(k) number K012878. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609?

THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Thermo Dma, Inc.. The 510(k) number is K012878.

When did THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 receive FDA 510(k) clearance?

THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 received FDA 510(k) clearance on 2001-10-16, under 510(k) number K012878.

Who is the listed applicant for THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609?

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

What is the FDA product code for THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609?

The FDA product code for THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 is JIS.

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Other records listing Thermo Dma, 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.

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Related Devices (Code: JIS)

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

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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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