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ADP Reagent, Modified

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952252

by Helena Laboratories

Identifiers

510(k) Number
K952252 FDA 510(k)
FDA Product Code
GHR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5700 FDA 510(k)
Regulation Number
864.5700 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ADP Reagent, Modified is a lyophilized reagent classified as a Reagent, Platelet Aggregation (product code GHR), designed for use in platelet aggregation studies. It contains adenosine-5-diphosphate and is intended for in vitro diagnostic testing to assess platelet function by measuring aggregation responses.

This reagent is supplied as a lyophilized preparation, available in 2 × 1 mL units, and is intended for single-use in clinical hematology settings. It is regulated under FDA 510(k) clearance (K952252) with a Traditional review pathway, falling under Class II – Special Controls for platelet aggregation reagents. No MRI safety or sterility specifications are noted in the regulatory data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ADP REAGENT, MODIFIED (K952252) — FDA 510 (k) | Innolitics, Product List | Helena Laboratories - Innovations for Science & Clinical ..., K952252 FDA 510 (k) - ADP REAGENT | Helena Laboratories, Platelet Aggregation | Helena Laboratories - Innovations for Science ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K952252 24 fields · synced Sep 19, 2026