S/P Sure-Cap

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812921 ↗

FDA Product Code

GIO

Device Class

Class I

Regulation

21 CFR Part 864.6150

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Creatine Kinase Mb Reagent

  Class II

  FDA 510(k) K840783 Active Cleared 4 Apr 1984

• Stratus Phenytoin Fluorometric Enzyme

  Class II

  FDA 510(k) K831154 Active Cleared 16 May 1983

• Lactate Reagent

  Class I

  FDA 510(k) K840778 Active Cleared 13 Apr 1984

• Paramax Iron Blank Reagent

  Class I

  FDA 510(k) K841887 Active Cleared 22 Jun 1984

• Immu-Trace T3 Uptake (T3U) Reagents

  Class II

  FDA 510(k) K803044 Active Cleared 2 Jan 1981

• Uric Acid Reagent

  Class I

  FDA 510(k) K840781 Active Cleared 13 Apr 1984

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