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FDA 510(k)

PLATELET AGGREGATION REAGENT SET

K-Number: K832428 · 1983-10-20

ApplicantHelena Laboratories
Decision Date1983-10-20
Product CodeGHR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGGREGATION REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-10-20 under 510(k) number K832428. 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 PLATELET AGGREGATION REAGENT SET?

PLATELET AGGREGATION REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-10-20. The listed applicant is Helena Laboratories. The 510(k) number is K832428.

When did PLATELET AGGREGATION REAGENT SET receive FDA 510(k) clearance?

PLATELET AGGREGATION REAGENT SET received FDA 510(k) clearance on 1983-10-20, under 510(k) number K832428.

Who is the listed applicant for PLATELET AGGREGATION REAGENT SET?

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 PLATELET AGGREGATION REAGENT SET?

The FDA product code for PLATELET AGGREGATION REAGENT SET is GHR.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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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.

K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAHelena LaboratoriesK952252ADP REAGENT, MODIFIEDHelena LaboratoriesK922800PLATELET AGGREGATION REAGENTSChrono-Log Corp.K910680EPINEPHRINE REAGENT, CAT. NO. 5367Helena LaboratoriesK910800ADP REAGENTHelena LaboratoriesK910706COLLAGEN REAGENT CAT. NO. 5368Helena Laboratories

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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