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FDA 510(k)

G7 AUTOMATED HPLC ANALYZER

K-Number: K011434 · 2001-09-18

ApplicantTosoh Medics, Inc.
Decision Date2001-09-18
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

G7 AUTOMATED HPLC ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 2001-09-18 under 510(k) number K011434. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G7 AUTOMATED HPLC ANALYZER?

G7 AUTOMATED HPLC ANALYZER is a medical device that received FDA 510(k) clearance on 2001-09-18. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K011434.

When did G7 AUTOMATED HPLC ANALYZER receive FDA 510(k) clearance?

G7 AUTOMATED HPLC ANALYZER received FDA 510(k) clearance on 2001-09-18, under 510(k) number K011434.

Who is the listed applicant for G7 AUTOMATED HPLC ANALYZER?

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

What is the FDA product code for G7 AUTOMATED HPLC ANALYZER?

The FDA product code for G7 AUTOMATED HPLC ANALYZER is LCP.

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Related Devices (Code: LCP)

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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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