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Liquichek Urianlysis Control (cat. No. 420 +4 more)

FDA 510(k)

Class I (US FDA 510(k))

510(k) K965171

by Bio-Rad

Identifiers

510(k) Number
K965171 FDA 510(k)
FDA Product Code
JJY FDA 510(k)
Models / Variants
cat. No. 420 FDA 510(k)
421 FDA 510(k)
422 FDA 510(k)
425 FDA 510(k)
426 FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 862.1660 FDA 510(k)
Regulation Number
862.1660 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Liquichek Urianlysis Control (cat. No. 420 +4 more) by Bio-Rad — Class I — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K965171 24 fields · synced Jun 19, 2026