The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Calcium, Catalogue Number140-20.
| Device ID | K895873 |
| 510k Number | K895873 |
| Device Name: | CALCIUM, CATALOGUE NUMBER140-20 |
| Classification | Azo Dye, Calcium |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 160 CHRISTIAN ST. Oxford, CT 06478 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 160 CHRISTIAN ST. Oxford, CT 06478 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-04 |
| Decision Date | 1989-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400270 | K895873 | 000 |
| 00628063400263 | K895873 | 000 |
| 00628063400256 | K895873 | 000 |