The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Gsc 1000.
| Device ID | K863566 |
| 510k Number | K863566 |
| Device Name: | GSC 1000 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Contact | Bogdan Dziurzynski |
| Correspondent | Bogdan Dziurzynski GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-12 |
| Decision Date | 1986-10-16 |