Centrifichem Triglyceoide Cali, Std. Set
FDA 510(k) K771216 · Union Carbide Corp.
510(k) numberK771216
Submission
- Device name
- Centrifichem Triglyceoide Cali, Std. Set
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- July 5, 1977
- Decision date
- July 21, 1977
- 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 Centrifichem Triglyceoide Cali, Std. Set cleared by the FDA?
Centrifichem Triglyceoide Cali, Std. Set (K771216) received a 510(k) decision of Substantially Equivalent on July 21, 1977, 16 days after the submission was received.
What is the product code of K771216?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.