Refractometric, Total Protein

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K933218 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• H.pylori Controls

  Class I

  FDA 510(k) K964675 Active Cleared 27 Jan 1997

• 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

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