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FDA 510(k)

NEOLYNX SCREENING APPLICATION MANAGER

K-Number: K003584 · 2001-03-19

ApplicantMicromass, Inc.
Decision Date2001-03-19
Product CodeJNB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEOLYNX SCREENING APPLICATION MANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Micromass, Inc.. It received FDA 510(k) clearance on 2001-03-19 under 510(k) number K003584. The device is classified under product code JNB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOLYNX SCREENING APPLICATION MANAGER?

NEOLYNX SCREENING APPLICATION MANAGER is a medical device that received FDA 510(k) clearance on 2001-03-19. The listed applicant is Micromass, Inc.. The 510(k) number is K003584.

When did NEOLYNX SCREENING APPLICATION MANAGER receive FDA 510(k) clearance?

NEOLYNX SCREENING APPLICATION MANAGER received FDA 510(k) clearance on 2001-03-19, under 510(k) number K003584.

Who is the listed applicant for NEOLYNX SCREENING APPLICATION MANAGER?

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

What is the FDA product code for NEOLYNX SCREENING APPLICATION MANAGER?

The FDA product code for NEOLYNX SCREENING APPLICATION MANAGER is JNB.

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Related Devices (Code: JNB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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