The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urine Reagent Strips-3 Parameters (modification).
| Device ID | K955438 |
| 510k Number | K955438 |
| Device Name: | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) |
| Classification | Indicator Method, Protein Or Albumin (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 | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-08 |
| Decision Date | 1996-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00664816000052 | K955438 | 000 |
| 20722355002181 | K955438 | 000 |
| 10673486000283 | K955438 | 000 |
| 10673486000276 | K955438 | 000 |
| 10673486000269 | K955438 | 000 |
| 10673486000238 | K955438 | 000 |
| 10673486000221 | K955438 | 000 |
| 10673486000214 | K955438 | 000 |