Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I and II
FDA 510(k) K952126 · Aalto Scientific, Ltd.
510(k) numberK952126
Submission
- Device name
- Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I and II
- Applicant
- Aalto Scientific, Ltd.
Vista, CA, US - Received
- May 8, 1995
- Decision date
- February 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I and II cleared by the FDA?
Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I and II (K952126) received a 510(k) decision of Substantially Equivalent on February 29, 1996, 297 days after the submission was received.
What is the product code of K952126?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.