KHM — Nephelometric, Amylase Class II
FDA Device Classification
Classification Details
- Product Code
- KHM
- Device Class
- Class II
- Regulation Number
- 862.1070
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K831295 | hi chem | AMYLASE REAGENT #88129 | June 30, 1983 |
| K812699 | pointe scientific, inc | AMYLASE | October 6, 1981 |
| K812447 | bioscientific | AMYLASE REAGENT KIT | September 9, 1981 |
| K801096 | stat engineering | PERKIN ELMER MODEL 91 AMYLASE REAGENT | June 9, 1980 |
| K790797 | alta diagnostics | AMYLASE REAGENT SET | July 17, 1979 |
| K770400 | bd becton dickinson vacutainer systems preanalytic | REAGENT, AMYLASE LIPASE | April 26, 1977 |