KHM
6 FDA 510(k) clearances · Product code
55 daysmedian time to decision
84 days90th percentile
6clearances measured
FDA profile
- Official device name
- Nephelometric, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMYLASE REAGENT #88129 (K831295) | Hi Chem, Inc. | 1983-06-30 |
| AMYLASE (K812699) | Pointe Scientific, Inc., | 1981-10-06 |
| AMYLASE REAGENT KIT (K812447) | Bioscientific | 1981-09-09 |
| PERKIN ELMER MODEL 91 AMYLASE REAGENT (K801096) | Stat Engineering | 1980-06-09 |
| AMYLASE REAGENT SET (K790797) | Alta Diagnostics, Inc. | 1979-07-17 |
| REAGENT, AMYLASE LIPASE (K770400) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
Track KHM automatically
Every clearance here is in the API, with alerts when new ones post.