The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Creatinine.
| Device ID | K880629 |
| 510k Number | K880629 |
| Device Name: | CREATININE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Contact | Happy Chen |
| Correspondent | Happy Chen TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-16 |
| Decision Date | 1988-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001532 | K880629 | 000 |
| 10673486001556 | K880629 | 000 |
| 10673486001549 | K880629 | 000 |
| 10673486001518 | K880629 | 000 |