Liquichek Ana Control, Nucleolar Pattern, Model 204
FDA 510(k) K984399 · Bio-Rad
510(k) numberK984399
Submission
- Device name
- Liquichek Ana Control, Nucleolar Pattern, Model 204
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- December 9, 1998
- Decision date
- December 18, 1998
- 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, Nucleolar Pattern, Model 204 cleared by the FDA?
Liquichek Ana Control, Nucleolar Pattern, Model 204 (K984399) received a 510(k) decision of Substantially Equivalent on December 18, 1998, 9 days after the submission was received.
What is the product code of K984399?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.