Bile Acids Controls
FDA 510(k) K873342 · Sigma Diagnostics, Inc.
510(k) numberK873342
Submission
- Device name
- Bile Acids Controls
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- August 19, 1987
- Decision date
- October 20, 1987
- 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 Bile Acids Controls cleared by the FDA?
Bile Acids Controls (K873342) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 62 days after the submission was received.
What is the product code of K873342?
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.