The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Sdl Trichrome Stain.
Device ID | K881598 |
510k Number | K881598 |
Device Name: | SDL TRICHROME STAIN |
Classification | Stains, Microbiologic |
Applicant | SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
Contact | Lipton, Phd |
Correspondent | Lipton, Phd SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
Product Code | JTS |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-13 |
Decision Date | 1988-05-04 |