The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Microalbumin Multi-calibrator Set.
| Device ID | K042243 |
| 510k Number | K042243 |
| Device Name: | MICROALBUMIN MULTI-CALIBRATOR SET |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, Prince Edward, CA C1e 2a6 |
| Contact | Nancy Olscamp |
| Correspondent | Nancy Olscamp DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, Prince Edward, CA C1e 2a6 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-19 |
| Decision Date | 2004-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400836 | K042243 | 000 |