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FDA 510(k)

AMERSE 2

K-Number: K983947 · 1998-12-04

ApplicantSTERIS Corporation
Decision Date1998-12-04
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMERSE 2 is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K983947. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERSE 2?

AMERSE 2 is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is STERIS Corporation. The 510(k) number is K983947.

When did AMERSE 2 receive FDA 510(k) clearance?

AMERSE 2 received FDA 510(k) clearance on 1998-12-04, under 510(k) number K983947.

Who is the listed applicant for AMERSE 2?

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

What is the FDA product code for AMERSE 2?

The FDA product code for AMERSE 2 is LRJ. This falls under the Clinical Lab category.

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Related Devices (Code: LRJ)

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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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