Liquichek Ena Control, Eia Screen, Model No. 206
FDA 510(k) K984462 · Bio-Rad
510(k) numberK984462
Submission
- Device name
- Liquichek Ena Control, Eia Screen, Model No. 206
- 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
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL · Traditional | Inova Diagnostics, Inc. | 06/01/2016SE |
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| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | Immco Diagnostics, Inc. | 03/31/2015SE |
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| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
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Questions and answers
When was Liquichek Ena Control, Eia Screen, Model No. 206 cleared by the FDA?
Liquichek Ena Control, Eia Screen, Model No. 206 (K984462) 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 K984462?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.