FDA 510(k)

SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING

K-Number: K943925 · 1994-10-04

Decision Date1994-10-04

Product CodeJJR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 1994-10-04 under 510(k) number K943925. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING?

SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Quantimetrix Corp.. The 510(k) number is K943925.

When did SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING receive FDA 510(k) clearance?

SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING received FDA 510(k) clearance on 1994-10-04, under 510(k) number K943925.

Who is the listed applicant for SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING?

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

What is the FDA product code for SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING?

The FDA product code for SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING is JJR.

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Related Devices (Code: JJR)

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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.