The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Ch Amylase_2 (amy_2).
| Device ID | K191454 |
| 510k Number | K191454 |
| Device Name: | Atellica CH Amylase_2 (AMY_2) |
| Classification | Catalytic Methods, Amylase |
| Applicant | Siemens Healthcare Diagnostics Inc. 500 GBC Drive P.O. Box 6101, M/S 514 Newark, DE 19714 |
| Contact | Catherine Daigle |
| Correspondent | Catherine Daigle Siemens Healthcare Diagnostics Inc. 500 GBC Drive P.O. Box 6101, M/S 514 Newark, DE 19714 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-31 |
| Decision Date | 2019-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414238357 | K191454 | 000 |