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FDA 510(k)

SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER

K-Number: K884035 · 1988-12-29

ApplicantSclavo, Inc.
Decision Date1988-12-29
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1988-12-29 under 510(k) number K884035. 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 SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER?

SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1988-12-29. The listed applicant is Sclavo, Inc.. The 510(k) number is K884035.

When did SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER receive FDA 510(k) clearance?

SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER received FDA 510(k) clearance on 1988-12-29, under 510(k) number K884035.

Who is the listed applicant for SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER?

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 SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER?

The FDA product code for SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER 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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