The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Phosphorus-sl Assay, Catalogue Number 117-10, 117-30.
| Device ID | K974858 |
| 510k Number | K974858 |
| Device Name: | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400850 | K974858 | 000 |
| 00628063400843 | K974858 | 000 |