The following data is part of a premarket notification filed by Gilford Instrument Laboratories, Inc. with the FDA for Data Acquisition & Collating Sys..
Device ID | K772344 |
510k Number | K772344 |
Device Name: | DATA ACQUISITION & COLLATING SYS. |
Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
Applicant | GILFORD INSTRUMENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJE |
CFR Regulation Number | 862.2160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-27 |
Decision Date | 1978-01-31 |