The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Silver Stain Reagent System.
Device ID | K871476 |
510k Number | K871476 |
Device Name: | SILVER STAIN REAGENT SYSTEM |
Classification | Stains, Dye Powder |
Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Contact | William Starkweather |
Correspondent | William Starkweather SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Product Code | LEF |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-14 |
Decision Date | 1987-05-21 |