The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere And Nucleolar Patterns, Catalog #131.
Device ID | K024230 |
510k Number | K024230 |
Device Name: | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 |
Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Contact | Yvette Lloyd |
Correspondent | Yvette Lloyd BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
Product Code | DHN |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-23 |
Decision Date | 2003-01-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847661000211 | K024230 | 000 |