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FDA 510(k)

INFLAMMA DRY

K-Number: K132066 · 2013-11-21

ApplicantRapid Pathogen Screening, Inc.
Decision Date2013-11-21
Product CodePFQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INFLAMMA DRY is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Pathogen Screening, Inc.. It received FDA 510(k) clearance on 2013-11-21 under 510(k) number K132066. The device is classified under product code PFQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFLAMMA DRY?

INFLAMMA DRY is a medical device that received FDA 510(k) clearance on 2013-11-21. The listed applicant is Rapid Pathogen Screening, Inc.. The 510(k) number is K132066.

When did INFLAMMA DRY receive FDA 510(k) clearance?

INFLAMMA DRY received FDA 510(k) clearance on 2013-11-21, under 510(k) number K132066.

Who is the listed applicant for INFLAMMA DRY?

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

What is the FDA product code for INFLAMMA DRY?

The FDA product code for INFLAMMA DRY is PFQ.

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.

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Other records listing Rapid Pathogen Screening, 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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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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