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 |