The following data is part of a premarket notification filed by International Newtech Development, Inc. with the FDA for Urinalysis Reagent Strips (10 Parameters).
| Device ID | K993850 |
| 510k Number | K993850 |
| Device Name: | URINALYSIS REAGENT STRIPS (10 PARAMETERS) |
| Classification | Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Applicant | INTERNATIONAL NEWTECH DEVELOPMENT, INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Contact | Dennis S.l. Hong |
| Correspondent | Dennis S.l. Hong INTERNATIONAL NEWTECH DEVELOPMENT, INC. 1629 FOSTERS WAY Delta, British Columbia, CA V3m 6s7 |
| Product Code | JMT |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | CIN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMZ |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 2000-01-03 |