The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Diastix Reagent Strips For Urinalysis.
| Device ID | K831600 |
| 510k Number | K831600 |
| Device Name: | DIASTIX REAGENT STRIPS FOR URINALYSIS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-18 |
| Decision Date | 1983-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301932806509 | K831600 | 000 |
| 40301932803218 | K831600 | 000 |