The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urine Reagents Strips-8 Parameters (modification).
| Device ID | K954977 |
| 510k Number | K954977 |
| Device Name: | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) |
| Classification | Refractometer For Clinical Use |
| 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 | JRE |
| Subsequent Product Code | CDM |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| CFR Regulation Number | 862.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1996-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486000399 | K954977 | 000 |
| 10673486000382 | K954977 | 000 |
| 10673486000405 | K954977 | 000 |