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FDA 510(k)

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA

K-Number: K061991 · 2007-02-23

ApplicantHelena Laboratories
Decision Date2007-02-23
Product CodeGHR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2007-02-23 under 510(k) number K061991. The device is classified under product code GHR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA?

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA is a medical device that received FDA 510(k) clearance on 2007-02-23. The listed applicant is Helena Laboratories. The 510(k) number is K061991.

When did PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA receive FDA 510(k) clearance?

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA received FDA 510(k) clearance on 2007-02-23, under 510(k) number K061991.

Who is the listed applicant for PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA?

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

What is the FDA product code for PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA?

The FDA product code for PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA is GHR.

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Related Devices (Code: GHR)

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.

K952252ADP REAGENT, MODIFIEDHelena LaboratoriesK922800PLATELET AGGREGATION REAGENTSChrono-Log Corp.K910706COLLAGEN REAGENT CAT. NO. 5368Helena LaboratoriesK910800ADP REAGENTHelena LaboratoriesK910680EPINEPHRINE REAGENT, CAT. NO. 5367Helena LaboratoriesK910286PLATELET AGGREGATION REAGENTSMedical Diagnostic Technologies, Inc.

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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