The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urine Reagent Strip-3 Parameters.
| Device ID | K940469 |
| 510k Number | K940469 |
| Device Name: | URINE REAGENT STRIP-3 PARAMETERS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| 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 | JIL |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIR |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486000313 | K940469 | 000 |
| 10673486000306 | K940469 | 000 |
| 10673486000290 | K940469 | 000 |