The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott A-gent Ld-1 Isozyme Reagent.
| Device ID | K871240 |
| 510k Number | K871240 |
| Device Name: | ABBOTT A-GENT LD-1 ISOZYME REAGENT |
| Classification | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Mary Zorc |
| Correspondent | Mary Zorc ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | JGF |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1987-05-13 |