510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KHMClass II

Nephelometric, Amylase

21 CFR 862.1070 / Clinical Chemistry
FDA source (opens on fda.gov)

KHM is the FDA product code for Nephelometric, Amylase, a class II device type, regulated under 21 CFR 862.1070. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KHM
Device name
Nephelometric, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code KHM

By decision year
6 clearances under product code KHM with a decision year between 1977 and 1983, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KHM by decision year
YearClearances
19771
19791
19801
19812
19831

Applicants with the most clearances

Product code KHM
Applicants holding the most 510(k) clearances under product code KHM
ApplicantClearances
Alta Diagnostics, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Bioscientific1
Hi Chem, Inc.1
Horiba Instruments Incorporated1
Stat Engineering1

Companies listing this code with FDA

Companies whose registered establishments list this code