Turbidimetric/Nephelometric Human Serum Reference Preparation
FDA 510(k) K981914 · The Binding Site, Ltd.
510(k) numberK981914
Submission
- Device name
- Turbidimetric/Nephelometric Human Serum Reference Preparation
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- June 1, 1998
- Decision date
- November 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Expedited review
- Yes
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 Turbidimetric/Nephelometric Human Serum Reference Preparation cleared by the FDA?
Turbidimetric/Nephelometric Human Serum Reference Preparation (K981914) received a 510(k) decision of Substantially Equivalent on November 26, 1999, 543 days after the submission was received.
What is the product code of K981914?
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.