Ace Controls, Normal & Elevated, No. A6040 & A7040
FDA 510(k) K860453 · Sigma Diagnostics, Inc.
510(k) numberK860453
Submission
- Device name
- Ace Controls, Normal & Elevated, No. A6040 & A7040
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- February 5, 1986
- Decision date
- February 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Ace Controls, Normal & Elevated, No. A6040 & A7040 cleared by the FDA?
Ace Controls, Normal & Elevated, No. A6040 & A7040 (K860453) received a 510(k) decision of Substantially Equivalent on February 19, 1986, 14 days after the submission was received.
What is the product code of K860453?
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.