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FDA 510(k)

PLATELETWORKS

K-Number: K990398 · 1999-12-01

ApplicantArray Medical, Inc.
Decision Date1999-12-01
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELETWORKS is the device name listed in this FDA 510(k) record. The listed applicant is Array Medical, Inc.. It received FDA 510(k) clearance on 1999-12-01 under 510(k) number K990398. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELETWORKS?

PLATELETWORKS is a medical device that received FDA 510(k) clearance on 1999-12-01. The listed applicant is Array Medical, Inc.. The 510(k) number is K990398.

When did PLATELETWORKS receive FDA 510(k) clearance?

PLATELETWORKS received FDA 510(k) clearance on 1999-12-01, under 510(k) number K990398.

Who is the listed applicant for PLATELETWORKS?

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

What is the FDA product code for PLATELETWORKS?

The FDA product code for PLATELETWORKS is JOZ.

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Other records listing Array Medical, Inc. as applicant

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Related Devices (Code: JOZ)

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

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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