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FDA 510(k)

CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC

K-Number: K896609 · 1990-01-31

ApplicantPhilips Medical Systems North America, Inc.
Decision Date1990-01-31
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 1990-01-31 under 510(k) number K896609. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC?

CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC is a medical device that received FDA 510(k) clearance on 1990-01-31. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K896609.

When did CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC receive FDA 510(k) clearance?

CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC received FDA 510(k) clearance on 1990-01-31, under 510(k) number K896609.

Who is the listed applicant for CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC?

The FDA product code for CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC is IZH.

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Other records listing Philips Medical Systems North America, 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.

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Related Devices (Code: IZH)

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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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