The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Acetaminophen-sl Assay, Catalogue # 505-10, 505-30..
| Device ID | K981059 |
| 510k Number | K981059 |
| Device Name: | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. |
| Classification | Colorimetry, Acetaminophen |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, P.e.i., CA C1e1b0 |
| Contact | Karen Callbeck, R.t.b.sc |
| Correspondent | Karen Callbeck, R.t.b.sc DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, P.e.i., CA C1e1b0 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-23 |
| Decision Date | 1998-05-12 |