FDA Product Code
FDA Product Code KHM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1070
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K831295 | AMYLASE REAGENT #88129 | Hi Chem, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K812699 | AMYLASE | Pointe Scientific, Inc., | 1981-10-06 | Traditional | PDF ↗ |
| K812447 | AMYLASE REAGENT KIT | Bioscientific | 1981-09-09 | Traditional | PDF ↗ |
| K801096 | PERKIN ELMER MODEL 91 AMYLASE REAGENT | Stat Engineering | 1980-06-09 | Traditional | PDF ↗ |
| K790797 | AMYLASE REAGENT SET | Alta Diagnostics, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K770400 | REAGENT, AMYLASE LIPASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 | Traditional | PDF ↗ |
Product code KHM · Class II · Clinical Chemistry. Data: openFDA.