H.pylori Controls

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964675 ↗

FDA Product Code

LYR

Device Class

Class I

Regulation

21 CFR Part 866.3110

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• B-Hcg Human Serum Controls

  Class I

  FDA 510(k) K932479 Active Cleared 2 Dec 1993

• Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

  Class II

  FDA 510(k) K952254 Active Cleared 16 Nov 1995

• Cmv Igg Human Serum Controls

  Class II

  FDA 510(k) K951800 Active Cleared 16 Nov 1995

• Hepatitis Negative Control

  Class I

  FDA 510(k) K962399 Active Cleared 2 Aug 1996

• Syphilis Igm Human Serum Controls

  Class II

  FDA 510(k) K961317 Active Cleared 24 Jun 1996

• Refractometric, Total Protein

  Class I

  FDA 510(k) K933218 Active Cleared 17 Feb 1994

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