The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Ld-1.
| Device ID | K981338 |
| 510k Number | K981338 |
| Device Name: | LD-1 |
| Classification | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Contact | Mike Littlefield |
| Correspondent | Mike Littlefield ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
| Product Code | JGF |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-05-18 |
| Summary: | summary |