Panels › Clinical Chemistry › Product code CIJ · Class 2
Saccharogenic, Amylase
Regulation 862.1070
0510(k)s in 12 months (31 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in CIJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Harleco | 4 | 0 |
| Behring Diagnostics, Inc. | 2 | 0 |
| Biotrol, USA, Inc. | 2 | 0 |
| Coulter Electronics, Inc. | 2 | 0 |
| Data Medical Associates, Inc. | 2 | 0 |
| Em Diagnostic Systems, Inc. | 2 | 0 |
| Pointe Scientific, Inc., | 2 | 0 |
| Randox Laboratories, Ltd. | 1 | 1 |
| Ac Biochemicals, Inc. | 1 | 0 |
| American Dade | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | RANDOX LABORATORIES, LTD. Amylase AY3805 batch 480449
Amylase Ethylidene Blocked-pNPG7 Reagent Terminated |
CIJ | K953211 |
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