The following data is part of a premarket notification filed by Laprol Scientific, Inc. with the FDA for Glucose 3, Inlab Reagent Strips-urinaly.
Device ID | K831499 |
510k Number | K831499 |
Device Name: | GLUCOSE 3, INLAB REAGENT STRIPS-URINALY |
Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
Applicant | LAPROL SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIN |
CFR Regulation Number | 862.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-11 |
Decision Date | 1983-06-17 |