The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Identicult-bl.
Device ID | K873509 |
510k Number | K873509 |
Device Name: | IDENTICULT-BL |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | SCOTT LABORATORIES, INC. 771 MAIN ST. West Warwick, RI 02893 |
Contact | Paul Campognone |
Correspondent | Paul Campognone SCOTT LABORATORIES, INC. 771 MAIN ST. West Warwick, RI 02893 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-31 |
Decision Date | 1987-10-15 |