The following data is part of a premarket notification filed by Shimadzu Precision Instruments, Inc. with the FDA for Micro-flow Spectrophotometer Cl-720.
Device ID | K801957 |
510k Number | K801957 |
Device Name: | MICRO-FLOW SPECTROPHOTOMETER CL-720 |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | SHIMADZU PRECISION INSTRUMENTS, INC. 21010 SOUTH VERMONT AVE. Torrance, CA 90502 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-18 |
Decision Date | 1980-09-26 |