The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Maternal Serum Control, Model 220.
Device ID | K984594 |
510k Number | K984594 |
Device Name: | LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Contact | Elizabeth Platt |
Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-28 |
Decision Date | 1999-02-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847661001751 | K984594 | 000 |
00847661001263 | K984594 | 000 |