The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Amylase Eps Reagent.
| Device ID | K070064 |
| 510k Number | K070064 |
| Device Name: | AMYLASE EPS REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | Thermo Fisher Scientific 189-199 BROWNS RD. Noble Park, Victoria, AU 3174 |
| Contact | Melita Lambiris |
| Correspondent | Melita Lambiris Thermo Fisher Scientific 189-199 BROWNS RD. Noble Park, Victoria, AU 3174 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-05 |
| Decision Date | 2007-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275002751 | K070064 | 000 |