The following data is part of a premarket notification filed by Gds Diagnostics with the FDA for Gds Enzymatic B-hydroxybutyrate Reagent Modified.
| Device ID | K910108 |
| 510k Number | K910108 |
| Device Name: | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | GDS DIAGNOSTICS 25235 LEER DR. P.O. BOX 473 Elkhart, IN 46515 |
| Contact | De Castro |
| Correspondent | De Castro GDS DIAGNOSTICS 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 | 1991-01-10 |
| Decision Date | 1991-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727011572 | K910108 | 000 |
| 00811727011558 | K910108 | 000 |