CKHClass II

Acid Phosphatase, Beta Glycerophosphate

21 CFR 862.1020 / Clinical Chemistry

CKH is the FDA product code for Acid Phosphatase, Beta Glycerophosphate, a class II device type, regulated under 21 CFR 862.1020. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: CKH
Device name: Acid Phosphatase, Beta Glycerophosphate
Regulation: 21 CFR 862.1020
Device class: Class II
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code CKH.

Recent clearances

Product code CKH

FDA records hold no clearances under product code CKH.

Recent recalls

Product code CKH

Z-1434-04Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature...Roche Diagnostics Corp. / initiated 2004-08-20 / 728 non-expired kits.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)