The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Amylase (ethylidene Pngpg7) Kit.
| Device ID | K953211 |
| 510k Number | K953211 |
| Device Name: | AMYLASE (ETHYLIDENE PNGPG7) KIT |
| Classification | Saccharogenic, Amylase |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1996-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200676 | K953211 | 000 |
| 05055273200652 | K953211 | 000 |
| 05055273200645 | K953211 | 000 |
| 05055273200607 | K953211 | 000 |
| 05055273200584 | K953211 | 000 |
| 05055273200577 | K953211 | 000 |
| 05055273200560 | K953211 | 000 |