The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Turbo Accelerator W/clin Diag Software Cartridge.
Device ID | K911438 |
510k Number | K911438 |
Device Name: | TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
Contact | Michael N Sevigny |
Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIHGLAND PARK BOX 998 Winooski, VT 05404 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-02 |
Decision Date | 1991-05-23 |