The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Acetaminophen-sl Assay.
| Device ID | K042330 |
| 510k Number | K042330 |
| Device Name: | ACETAMINOPHEN-SL ASSAY |
| Classification | Colorimetry, Acetaminophen |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, Prince Edward, CA C1e 2a6 |
| Contact | Nancy Olscamp |
| Correspondent | Nancy Olscamp DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, Prince Edward, CA C1e 2a6 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-27 |
| Decision Date | 2005-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740003661 | K042330 | 000 |