Product code CHO— Clinical Chemistry

FDA has cleared 6 devices under product code CHO between 1981 and 1986, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19861 clearance
• 19851 clearance
• 19841 clearance
• 19831 clearance
• 19812 clearances

• Immuno Nuclear Corp.2 clearances
• New England Nuclear1 clearance
• King Diagnostics, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• Amersham Corp.1 clearance

• K860253 — AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)Amersham Corp.·1986-03-14
• K844135 — PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMUImmuno Nuclear Corp.·1985-03-05
• K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAYNew England Nuclear·1984-06-14
• K823504 — CYCLIC ADENOSINE MONOPHOSHATE BY RADIOImmuno Nuclear Corp.·1983-01-28
• K811746 — KING DIAGNOSTICS CHOLESTEROL-FE TESTKing Diagnostics, Inc.·1981-07-10
• K811273 — CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]Bd Becton Dickinson Vacutainer Systems Preanalytic·1981-05-27