The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Direct Bilirubin Reagent.
Device ID | K011972 |
510k Number | K011972 |
Device Name: | DIRECT BILIRUBIN REAGENT |
Classification | Diazo Colorimetry, Bilirubin |
Applicant | INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview, WA 98632 |
Contact | Mark E Legaz |
Correspondent | Mark E Legaz INTERSECT SYSTEMS, INC. P.O. BOX 2219 Longview, WA 98632 |
Product Code | CIG |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-25 |
Decision Date | 2001-08-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851445007204 | K011972 | 000 |
00851445007198 | K011972 | 000 |