Refractrol-Sp
FDA 510(k) K926095 · Medical Specialties, Inc.
510(k) numberK926095
Submission
- Device name
- Refractrol-Sp
- Applicant
- Medical Specialties, Inc.
South Plainfield, NJ, US - Received
- December 2, 1992
- Decision date
- January 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Refractrol-Sp cleared by the FDA?
Refractrol-Sp (K926095) received a 510(k) decision of Substantially Equivalent on January 26, 1993, 55 days after the submission was received.
What is the product code of K926095?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.