Centrifichem Triglyceride Cali. Std.
FDA 510(k) K771215 · Union Carbide Corp.
510(k) numberK771215
Submission
- Device name
- Centrifichem Triglyceride Cali. Std.
- 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 Triglyceride Cali. Std. cleared by the FDA?
Centrifichem Triglyceride Cali. Std. (K771215) 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 K771215?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.