The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Histomatic Slide Stainer, Code-on Version.
Device ID | K872916 |
510k Number | K872916 |
Device Name: | HISTOMATIC SLIDE STAINER, CODE-ON VERSION |
Classification | Slide Stainer, Automated |
Applicant | FISHER SCIENTIFIC CO., LLC. 1410 WAYNE AVE. Indiana, PA 15701 |
Contact | Dean C Hobson |
Correspondent | Dean C Hobson FISHER SCIENTIFIC CO., LLC. 1410 WAYNE AVE. Indiana, PA 15701 |
Product Code | KPA |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-24 |
Decision Date | 1987-09-14 |