Vigil Hemoglobin (Hbalc) Controls
FDA 510(k) K982022 · Beckman Coulter, Inc.
510(k) numberK982022
Submission
- Device name
- Vigil Hemoglobin (Hbalc) Controls
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- June 9, 1998
- Decision date
- July 6, 1998
- 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 Vigil Hemoglobin (Hbalc) Controls cleared by the FDA?
Vigil Hemoglobin (Hbalc) Controls (K982022) received a 510(k) decision of Substantially Equivalent on July 6, 1998, 27 days after the submission was received.
What is the product code of K982022?
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.