The following data is part of a premarket notification filed by Genzyme Diagnostics P.e.i. Inc. with the FDA for Acetaminophen L3k Assay, And Acetaminophen L3k Assay, Models 506-10, 506-30.
| Device ID | K081938 |
| 510k Number | K081938 |
| Device Name: | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 |
| Classification | Colorimetry, Acetaminophen |
| Applicant | GENZYME DIAGNOSTICS P.E.I. INC. 700 WATTS AVENUE Charlottetown, Prin Ed Island, CA C1e 2b9 |
| Contact | Penny J White |
| Correspondent | Penny J White GENZYME DIAGNOSTICS P.E.I. INC. 700 WATTS AVENUE Charlottetown, Prin Ed Island, CA C1e 2b9 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-08 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400034 | K081938 | 000 |
| 00628063400027 | K081938 | 000 |