Secondary Calibrators
FDA 510(k) K904698 · Bionostics, Inc.
510(k) numberK904698
Submission
- Device name
- Secondary Calibrators
- Applicant
- Bionostics, Inc.
Acton, MA, US - Received
- October 16, 1990
- Decision date
- November 28, 1990
- 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 Secondary Calibrators cleared by the FDA?
Secondary Calibrators (K904698) received a 510(k) decision of Substantially Equivalent on November 28, 1990, 43 days after the submission was received.
What is the product code of K904698?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.