The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Slide Culture U 'eiken'.
Device ID | K861631 |
510k Number | K861631 |
Device Name: | SLIDE CULTURE U 'EIKEN' |
Classification | Kit, Screening, Urine |
Applicant | SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
Contact | James F Godfrey |
Correspondent | James F Godfrey SYN-KIT, INC. 9231 ETON AVE. Chatsworth, CA 91311 |
Product Code | JXA |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-29 |
Decision Date | 1986-06-10 |