The following data is part of a premarket notification filed by Elite Technology, Inc. with the FDA for Protein Test For Urine And Csf.
| Device ID | K900733 |
| 510k Number | K900733 |
| Device Name: | PROTEIN TEST FOR URINE AND CSF |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | ELITE TECHNOLOGY, INC. #1 - 57 GALAXY BLVD. TORONTO, ONTARIO Canada M9w 5p1, CA |
| Contact | Clifford Hatcher |
| Correspondent | Clifford Hatcher ELITE TECHNOLOGY, INC. #1 - 57 GALAXY BLVD. TORONTO, ONTARIO Canada M9w 5p1, CA |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-07-10 |