Cholesterol Calibrator
FDA 510(k) K761197 · Beckman Instruments, Inc.
510(k) numberK761197
Submission
- Device name
- Cholesterol Calibrator
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- December 6, 1976
- Decision date
- December 21, 1976
- 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 Cholesterol Calibrator cleared by the FDA?
Cholesterol Calibrator (K761197) received a 510(k) decision of Substantially Equivalent on December 21, 1976, 15 days after the submission was received.
What is the product code of K761197?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.