The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Dc-lineate Cat. No. Se-091.
| Device ID | K932555 |
| 510k Number | K932555 |
| Device Name: | DC-LINEATE CAT. NO. SE-091 |
| Classification | Calibrator, Primary |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-26 |
| Decision Date | 1993-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400485 | K932555 | 000 |