The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Dc-bilitrol Catalogue # Se-021, Se-022, Se-023.
| Device ID | K882259 |
| 510k Number | K882259 |
| Device Name: | DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 |
| Classification | Calibrator, Secondary |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Duffy, Phd |
| Correspondent | Duffy, Phd DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-31 |
| Decision Date | 1988-07-21 |