Synchron Enzyme Validator Set
FDA 510(k) K951964 · Beckman Instruments, Inc.
510(k) numberK951964
Submission
- Device name
- Synchron Enzyme Validator Set
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- April 27, 1995
- Decision date
- June 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Synchron Enzyme Validator Set cleared by the FDA?
Synchron Enzyme Validator Set (K951964) received a 510(k) decision of Substantially Equivalent on June 29, 1995, 63 days after the submission was received.
What is the product code of K951964?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.