KHM · Class II · 21 CFR 862.1070

FDA Product Code KHM: Nephelometric, Amylase

Leading manufacturers include Pointe Scientific, Inc.,, Hi Chem, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

6

Total

6

Cleared

45d

Avg days

1977

Since

FDA 510(k) Cleared Nephelometric, Amylase Devices (Product Code KHM)

6 devices

1–6 of 6

Cleared Jun 30, 1983

AMYLASE REAGENT #88129

Chemistry · 71d

Cleared Oct 06, 1981

Pointe Scientific, Inc.,

Chemistry · 14d

Cleared Apr 26, 1977

REAGENT, AMYLASE LIPASE

Bd Becton Dickinson Vacutainer Systems Preanalytic

Chemistry · 55d

About Product Code KHM - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Jun 30, 1983

Product Code Info

Code	KHM
Device class	Class II
CFR	21 CFR 862.1070
Panel	Chemistry

Verify on FDA.gov

View KHM classification on FDA.gov →