The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Fisher Diagnostics Hematall Iii Las Reagent.
| Device ID | K874054 |
| 510k Number | K874054 |
| Device Name: | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT |
| Classification | Products, Red-cell Lysing Products |
| Applicant | FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | B Breuer,phd |
| Correspondent | B Breuer,phd FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1987-10-20 |