Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed Liquid Chemistry Control Levels

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

510(k) Number

K973469 ↗

FDA Product Code

JJY

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Qualitrol Dhp Immunoassay Control Levels 1, 2 and 3, Conformancee Mcc-Ligand Control Levels 1, 2 and 3

  Class I

  FDA 510(k) K972080 Active Cleared 18 Jun 1997

• Qualitrol, (Alfa Fetoprotein) Afp Control Set

  Class I

  FDA 510(k) K961912 Active Cleared 15 Aug 1996

• Qualitrol Rf Controls

  Class II

  FDA 510(k) K961545 Active Cleared 24 Sep 1996

• Qualitrol Syphsero Control Set

  Class II

  FDA 510(k) K961998 Active Cleared 8 Aug 1996

• Qualitrol CRP Control Set

  Class II

  FDA 510(k) K961829 Active Cleared 19 Aug 1996

• Urine Chemistry Control, Level 2

  Class I

  FDA 510(k) K992578 Active Cleared 3 Sep 1999

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