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FDA 510(k)

ILAB 600 CLINICAL CHEMISTRY SYSTEM

K-Number: K980757 · 1998-04-21

ApplicantInstrumentation Laboratory CO
Decision Date1998-04-21
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ILAB 600 CLINICAL CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K980757. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILAB 600 CLINICAL CHEMISTRY SYSTEM?

ILAB 600 CLINICAL CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K980757.

When did ILAB 600 CLINICAL CHEMISTRY SYSTEM receive FDA 510(k) clearance?

ILAB 600 CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance on 1998-04-21, under 510(k) number K980757.

Who is the listed applicant for ILAB 600 CLINICAL CHEMISTRY SYSTEM?

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

What is the FDA product code for ILAB 600 CLINICAL CHEMISTRY SYSTEM?

The FDA product code for ILAB 600 CLINICAL CHEMISTRY SYSTEM is CGZ.

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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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