The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Dc-trol Level 1 Or 2.
| Device ID | K874772 |
| 510k Number | K874772 |
| Device Name: | DC-TROL LEVEL 1 OR 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Contact | David Templeton |
| Correspondent | David Templeton DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-19 |
| Decision Date | 1988-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400461 | K874772 | 000 |
| 00628063400454 | K874772 | 000 |