The following data is part of a premarket notification filed by Genzyme Diagnostics P.e.i. Inc. with the FDA for Total Bilirubin L3k, Model 295-10 And 295-30.
| Device ID | K082210 |
| 510k Number | K082210 |
| Device Name: | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | GENZYME DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE Charlottetown, Prin Ed Island, CA C1e 2b9 |
| Contact | Penny J White |
| Correspondent | Penny J White GENZYME DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE Charlottetown, Prin Ed Island, CA C1e 2b9 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-06 |
| Decision Date | 2008-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400171 | K082210 | 000 |