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FDA 510(k)

UNI-FAST ANALYZER SYSTEM

K-Number: K840129 · 1984-03-23

ApplicantSclavo, Inc.
Decision Date1984-03-23
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNI-FAST ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840129. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-FAST ANALYZER SYSTEM?

UNI-FAST ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Sclavo, Inc.. The 510(k) number is K840129.

When did UNI-FAST ANALYZER SYSTEM receive FDA 510(k) clearance?

UNI-FAST ANALYZER SYSTEM received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840129.

Who is the listed applicant for UNI-FAST ANALYZER SYSTEM?

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

What is the FDA product code for UNI-FAST ANALYZER SYSTEM?

The FDA product code for UNI-FAST ANALYZER SYSTEM is JJE.

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Related Devices (Code: JJE)

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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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