The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Chem 1 Clinical Analyzer (method Urine Creatinine).
| Device ID | K901229 |
| 510k Number | K901229 |
| Device Name: | CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | C Brewter,phd |
| Correspondent | C Brewter,phd TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-14 |
| Decision Date | 1990-05-04 |