Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity CONTROL-LEVEL1,2,3,4,5,AND 6
FDA 510(k) K964278 · Clinical Controls, Inc.
510(k) numberK964278
Submission
- Device name
- Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity CONTROL-LEVEL1,2,3,4,5,AND 6
- Applicant
- Clinical Controls, Inc.
Grover Beach, CA, US - Received
- October 28, 1996
- Decision date
- November 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity CONTROL-LEVEL1,2,3,4,5,AND 6 cleared by the FDA?
Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity CONTROL-LEVEL1,2,3,4,5,AND 6 (K964278) received a 510(k) decision of Substantially Equivalent on November 22, 1996, 25 days after the submission was received.
What is the product code of K964278?
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.