The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Enzymatic Acetaminophen Assay.
| Device ID | K841930 |
| 510k Number | K841930 |
| Device Name: | ENZYMATIC ACETAMINOPHEN ASSAY |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Product Code | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-10 |
| Decision Date | 1984-06-25 |