Panels › Clinical Chemistry › Product code KHM · Class 2
Nephelometric, Amylase
Regulation 862.1070
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KHM
| Company | 510(k)s | Recalls |
|---|---|---|
| Alta Diagnostics, Inc. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Bioscientific | 1 | 0 |
| Hi Chem, Inc. | 1 | 0 |
| Pointe Scientific, Inc., | 1 | 0 |
| Stat Engineering | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 1983 | K831295 | AMYLASE REAGENT #88129 Hi Chem, Inc. | KHM |
| Oct 6, 1981 | K812699 | AMYLASE Pointe Scientific, Inc., | KHM |
| Sep 9, 1981 | K812447 | AMYLASE REAGENT KIT Bioscientific | KHM |
| Jun 9, 1980 | K801096 | PERKIN ELMER MODEL 91 AMYLASE REAGENT Stat Engineering | KHM |
| Jul 17, 1979 | K790797 | AMYLASE REAGENT SET Alta Diagnostics, Inc. | KHM |
| Apr 26, 1977 | K770400 | REAGENT, AMYLASE LIPASE Bd Becton Dickinson Vacutainer Systems Preanalytic | KHM |
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