Enzymatic Theophylline Reagent, #500-82

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K901510 ↗

FDA Product Code

KLS

Device Class

Class II

Regulation

21 CFR Part 862.3880

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Calcium, Catalogue Number 122-20

  Class II

  FDA 510(k) K881054 Active Cleared 18 Apr 1988

• Vma Assay Kit

  Class I

  FDA 510(k) K843379 Active Cleared 28 Sep 1984

• Aspartate Aminotransferase Assay Kit (Ifcc)

  Class II

  FDA 510(k) K880692 Active Cleared 27 May 1988

• Acid Phosphatase (Kinetic) Cat. # 320-06

  Class II

  FDA 510(k) K875209 Active Cleared 1 Feb 1988

• Serum Iron & Serum Iron Binding Capacity

  Class I

  FDA 510(k) K842156 Active Cleared 7 Aug 1984

• Chloride Cat. # 152-17

  Class II

  FDA 510(k) K875208 Active Cleared 18 Apr 1988

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