The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Clinistrip.
| Device ID | K970250 |
| 510k Number | K970250 |
| Device Name: | CLINISTRIP |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Andrew Reams |
| Correspondent | Andrew Reams TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JJR |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-22 |
| Decision Date | 1997-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00664816000045 | K970250 | 000 |
| 10673486000030 | K970250 | 000 |
| 10673486000047 | K970250 | 000 |
| 10673486000054 | K970250 | 000 |
| 10673486000061 | K970250 | 000 |
| 10673486000078 | K970250 | 000 |
| 10673486000450 | K970250 | 000 |
| 10673486000627 | K970250 | 000 |
| 10673486000634 | K970250 | 000 |
| 10673486000641 | K970250 | 000 |
| 20722355002204 | K970250 | 000 |
| 20722355002198 | K970250 | 000 |
| 10673486000672 | K970250 | 000 |
| 00664816000021 | K970250 | 000 |
| 10673486000023 | K970250 | 000 |