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Liquichec Blood Gas Pluse Control With Glucose (511 +2 more)

FDA 510(k)

Class I (US FDA 510(k))

510(k) K002535

by Bio-Rad

Identifiers

510(k) Number
K002535 FDA 510(k)
FDA Product Code
JJS FDA 510(k)
Models / Variants
511 FDA 510(k)
512 FDA 510(k)
513 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)

Liquichec Blood Gas Pluse Control With Glucose (511 +2 more) by Bio-Rad — Class I — FDA_510K — listed in FDA 510(k) — 3 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) K002535 24 fields · synced Jun 18, 2026