The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Urinary/cebrospinal Fluid Protein Calibrator.
| Device ID | K934843 |
| 510k Number | K934843 |
| Device Name: | URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. BMP22/1170 Wilmington, DE 19880 -0022 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George E.I. DUPONT DE NEMOURS & CO., INC. BMP22/1170 Wilmington, DE 19880 -0022 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-08 |
| Decision Date | 1994-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005152 | K934843 | 000 |