Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model 6C06-05

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042335 ↗

FDA Product Code

JJY

Models / Variants

Architect Free Psa Mastercheck, Model 6C07-05

Architect Tital Psa Mastercheck, Model 6C06-05

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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  Class II

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• Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

  Class II

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• Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200

  Class II

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  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

See all devices from Bio-Rad Laboratories, Inc. →