The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Pancreatic Amylase, Ethylidene Blocked-pnpg7 Enzyme Colorimetric Test.
| Device ID | K971825 |
| 510k Number | K971825 |
| Device Name: | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST |
| Classification | Catalytic Methods, Amylase |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | Pone Armstrong |
| Correspondent | Pone Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-16 |
| Decision Date | 1997-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595641 | K971825 | 000 |
| 00630414510156 | K971825 | 000 |
| 05055273200669 | K971825 | 000 |
| 05055273200614 | K971825 | 000 |
| 05055273200591 | K971825 | 000 |