Product code KHM— Clinical Chemistry

FDA has cleared 6 devices under product code KHM between 1977 and 1983, filed by 6 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.

• 19831 clearance
• 19812 clearances
• 19801 clearance
• 19791 clearance
• 19771 clearance

• Stat Engineering1 clearance
• Pointe Scientific, Inc.,1 clearance
• Hi Chem, Inc.1 clearance
• Bioscientific1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• Alta Diagnostics, Inc.1 clearance

• K831295 — AMYLASE REAGENT #88129Hi Chem, Inc.·1983-06-30
• K812699 — AMYLASEPointe Scientific, Inc.,·1981-10-06
• K812447 — AMYLASE REAGENT KITBioscientific·1981-09-09
• K801096 — PERKIN ELMER MODEL 91 AMYLASE REAGENTStat Engineering·1980-06-09
• K790797 — AMYLASE REAGENT SETAlta Diagnostics, Inc.·1979-07-17
• K770400 — REAGENT, AMYLASE LIPASEBd Becton Dickinson Vacutainer Systems Preanalytic·1977-04-26