Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118
FDA 510(k) K024221 · Bio-Rad
510(k) numberK024221
Submission
- Device name
- Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- December 23, 2002
- Decision date
- January 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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Questions and answers
When was Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118 cleared by the FDA?
Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118 (K024221) received a 510(k) decision of Substantially Equivalent on January 15, 2003, 23 days after the submission was received.
What is the product code of K024221?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.