Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige Co
FDA 510(k) K134013 · Bio-Rad Laboratories
510(k) numberK134013
Submission
- Device name
- Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige Co
- Applicant
- Bio-Rad Laboratories
Irvine, CA, US - Received
- December 30, 2013
- Decision date
- April 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige Co cleared by the FDA?
Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige Co (K134013) received a 510(k) decision of Substantially Equivalent on April 24, 2014, 115 days after the submission was received.
What is the product code of K134013?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.