Cholesterol Calibrators
FDA 510(k) K861314 · Sigma Diagnostics, Inc.
510(k) numberK861314
Submission
- Device name
- Cholesterol Calibrators
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- April 8, 1986
- Decision date
- July 1, 1986
- 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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| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
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| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
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Questions and answers
When was Cholesterol Calibrators cleared by the FDA?
Cholesterol Calibrators (K861314) received a 510(k) decision of Substantially Equivalent on July 1, 1986, 84 days after the submission was received.
What is the product code of K861314?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.