The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Microhematocrit Rotor.
Device ID | K930415 |
510k Number | K930415 |
Device Name: | MICROHEMATOCRIT ROTOR |
Classification | Centrifuge, Hematocrit |
Applicant | FISHER SCIENTIFIC CO., LLC. 711 FORBES AVE. Pittsburgh, PA 15219 |
Contact | Donna Chesna |
Correspondent | Donna Chesna FISHER SCIENTIFIC CO., LLC. 711 FORBES AVE. Pittsburgh, PA 15219 |
Product Code | GKG |
CFR Regulation Number | 864.6400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-26 |
Decision Date | 1993-03-23 |