The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urine Reagent Strips-8 Parameters.
| Device ID | K943436 |
| 510k Number | K943436 |
| Device Name: | URINE REAGENT STRIPS-8 PARAMETERS |
| Classification | Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.) |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | K. C. Chen |
| Correspondent | K. C. Chen TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | JJB |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JMT |
| CFR Regulation Number | 862.1115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-18 |
| Decision Date | 1995-04-24 |