V8 SP Normal Control, Abnormal Control
FDA 510(k) K131479 · Helena Laboratories
510(k) numberK131479
Submission
- Device name
- V8 SP Normal Control, Abnormal Control
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- May 22, 2013
- Decision date
- October 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 V8 SP Normal Control, Abnormal Control cleared by the FDA?
V8 SP Normal Control, Abnormal Control (K131479) received a 510(k) decision of Substantially Equivalent on October 7, 2013, 138 days after the submission was received.
What is the product code of K131479?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.