The following data is part of a premarket notification filed by Gds Technology, Llc. with the FDA for Ketosite(tm)/stat-site(tm)/ketosite(tm) Low-hi Con.
| Device ID | K911801 |
| 510k Number | K911801 |
| Device Name: | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | GDS TECHNOLOGY, LLC. 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Contact | De Castro |
| Correspondent | De Castro GDS TECHNOLOGY, LLC. 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-23 |
| Decision Date | 1991-07-01 |