Flow Cytometry Fitc/Pe Compensation Kit
FDA 510(k) K910255 · Sigma Diagnostics, Inc.
510(k) numberK910255
Submission
- Device name
- Flow Cytometry Fitc/Pe Compensation Kit
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- January 22, 1991
- Decision date
- April 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Flow Cytometry Fitc/Pe Compensation Kit cleared by the FDA?
Flow Cytometry Fitc/Pe Compensation Kit (K910255) received a 510(k) decision of Substantially Equivalent on April 3, 1991, 71 days after the submission was received.
What is the product code of K910255?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.