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C-Reactive Protein (crp):a Latex Slide Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962019

by Teco Diagnostics

Identifiers

510(k) Number
K962019 FDA 510(k)
FDA Product Code
DCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5270 FDA 510(k)
Regulation Number
866.5270 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

C-Reactive Protein (crp):a Latex Slide Test by Teco Diagnostics — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA 510(k) K962019 24 fields · synced Jun 19, 2026