The following data is part of a premarket notification filed by Chimera Research & Chemical, Inc. with the FDA for Automated Analysis Assay For Bilirubin In Urine.
| Device ID | K951877 |
| 510k Number | K951877 |
| Device Name: | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE |
| Classification | Automated Urinalysis System |
| Applicant | CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
| Contact | Charles A Hay |
| Correspondent | Charles A Hay CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1996-05-14 |