The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Lactate Dehydrogenase (ld).
| Device ID | K970684 |
| 510k Number | K970684 |
| Device Name: | LACTATE DEHYDROGENASE (LD) |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| 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 | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-24 |
| Decision Date | 1997-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273204148 | K970684 | 000 |
| 05055273204131 | K970684 | 000 |
| 05055273204124 | K970684 | 000 |
| 05055273204117 | K970684 | 000 |
| 05055273204100 | K970684 | 000 |