Nephelometric, Amylase
Nephelometric Amylase is an in vitro diagnostic device that uses nephelometric measurement techniques to quantify amylase enzyme activity in patient serum or urine samples, aiding in the diagnosis and monitoring of pancreatitis, salivary gland disorders, and other conditions associated with elevated amylase levels. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHM, regulated under 21 CFR 862.1070, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KHM
- Device Class
- FDA class 2
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831295 | AMYLASE REAGENT #88129 | Jun 30, 1983 | Substantially Equivalent | Hi Chem, Inc. |
| K812699 | AMYLASE | Oct 06, 1981 | Substantially Equivalent | Pointe Scientific, Inc., |
| K812447 | AMYLASE REAGENT KIT | Sep 09, 1981 | Substantially Equivalent | Bioscientific |
| K801096 | PERKIN ELMER MODEL 91 AMYLASE REAGENT | Jun 09, 1980 | Substantially Equivalent | Stat Engineering |
| K790797 | AMYLASE REAGENT SET | Jul 17, 1979 | Substantially Equivalent | Alta Diagnostics, Inc. |
| K770400 | REAGENT, AMYLASE LIPASE | Apr 26, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.