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CardioChek® PA analyzer

POLYMER TECHNOLOGY SYSTEMS, INC. · Model 1708 · UDI-DI 00381931708013

NAQCGALBRCHHJGYNGONBW Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities

Description

The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.

Recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.