Bile Acids Calibrator
FDA 510(k) K872451 · Sigma Diagnostics, Inc.
510(k) numberK872451
Submission
- Device name
- Bile Acids Calibrator
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- June 23, 1987
- Decision date
- August 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Bile Acids Calibrator cleared by the FDA?
Bile Acids Calibrator (K872451) received a 510(k) decision of Substantially Equivalent on August 21, 1987, 59 days after the submission was received.
What is the product code of K872451?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.