The following data is part of a premarket notification filed by Shandon, Inc. with the FDA for Linistain Sls.
Device ID | K890984 |
510k Number | K890984 |
Device Name: | LINISTAIN SLS |
Classification | Slide Stainer, Immersion Type |
Applicant | SHANDON, INC. 171 INDUSTRY DR. Pittsburgh, PA 15275 |
Contact | Crookham, Ba |
Correspondent | Crookham, Ba SHANDON, INC. 171 INDUSTRY DR. Pittsburgh, PA 15275 |
Product Code | KIO |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-27 |
Decision Date | 1989-04-04 |