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FDA 510(k)

LEICA AT550

K-Number: K990869 · 1999-06-07

ApplicantLeica Microsystems, Inc.
Decision Date1999-06-07
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LEICA AT550 is the device name listed in this FDA 510(k) record. The listed applicant is Leica Microsystems, Inc.. It received FDA 510(k) clearance on 1999-06-07 under 510(k) number K990869. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEICA AT550?

LEICA AT550 is a medical device that received FDA 510(k) clearance on 1999-06-07. The listed applicant is Leica Microsystems, Inc.. The 510(k) number is K990869.

When did LEICA AT550 receive FDA 510(k) clearance?

LEICA AT550 received FDA 510(k) clearance on 1999-06-07, under 510(k) number K990869.

Who is the listed applicant for LEICA AT550?

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

What is the FDA product code for LEICA AT550?

The FDA product code for LEICA AT550 is HKX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Leica Microsystems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061871LEICA MODEL FL800

Related Devices (Code: HKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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