The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Whole Blood Volatiles Control.
Device ID | K041561 |
510k Number | K041561 |
Device Name: | LIQUICHEK WHOLE BLOOD VOLATILES CONTROL |
Classification | Drug Mixture Control Materials |
Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Contact | Maria Zeballos |
Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Product Code | DIF |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-10 |
Decision Date | 2004-07-06 |
Summary: | summary |