Liquichek Anti-Ss-A Control, Eia, Model 209
FDA 510(k) K984470 · Bio-Rad
510(k) numberK984470
Submission
- Device name
- Liquichek Anti-Ss-A Control, Eia, Model 209
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- December 16, 1998
- Decision date
- December 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKJ – Antinuclear Antibody, 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 Anti-Ss-A Control, Eia, Model 209 cleared by the FDA?
Liquichek Anti-Ss-A Control, Eia, Model 209 (K984470) received a 510(k) decision of Substantially Equivalent on December 22, 1998, 6 days after the submission was received.
What is the product code of K984470?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.