Light Diagnostics Pneumocystis Carinii Dfa, Model 31965

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K992252 ↗

FDA Product Code

LYF

Device Class

Class II

Regulation

21 CFR Part 866.3780

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Coxsackievirus B1 Monoclonal Antibody

  Class I

  FDA 510(k) K936145 Active Cleared 8 Sep 1995

• Enterovirus Monocl Antibody Det of Coxsackie A9 Virus

  Class I

  FDA 510(k) K936073 Active Cleared 8 Sep 1995

• Coxsackievirus B5 Monoclonal Antibody

  Class I

  FDA 510(k) K940472 Active Cleared 8 Sep 1995

• Enterovirus 71 Monoclonal Antibody

  Class I

  FDA 510(k) K940473 Active Cleared 12 Sep 1995

• Enterovirus Blend Monoclonal Antibodies

  Class I

  FDA 510(k) K940027 Active Cleared 12 Sep 1995

• Coxsackievirus B Blend Monoclonal Antibodies

  Class I

  FDA 510(k) K940471 Active Cleared 8 Sep 1995

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