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FDA 510(k)

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4

K-Number: K050125 · 2005-03-18

Decision Date2005-03-18
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 2005-03-18 under 510(k) number K050125. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4?

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 is a medical device that received FDA 510(k) clearance on 2005-03-18. The listed applicant is More Diagnostics. The 510(k) number is K050125.

When did RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 receive FDA 510(k) clearance?

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 received FDA 510(k) clearance on 2005-03-18, under 510(k) number K050125.

Who is the listed applicant for RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4?

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

What is the FDA product code for RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4?

The FDA product code for RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 is JJY.

Related Clinical Trials

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.

Other records listing More Diagnostics 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: JJY)

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.

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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