Product code

CKH: Acid phosphatase, beta glycerophosphate

FDA product code · Class II · Clinical Chemistry

Key facts

Product code CKH
Device Acid phosphatase, beta glycerophosphate
Device class Class II
Regulation number 862.1020
Review panel Clinical Chemistry
Medical specialty Clinical Chemistry
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • None MAUDE adverse event reports
  • 1–9 Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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