Coulter Counter Model T-660
FDA 510(k) K854114 · Coulter Electronics, Inc.
510(k) numberK854114
Submission
- Device name
- Coulter Counter Model T-660
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- October 8, 1985
- Decision date
- November 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
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Questions and answers
When was Coulter Counter Model T-660 cleared by the FDA?
Coulter Counter Model T-660 (K854114) received a 510(k) decision of Substantially Equivalent on November 5, 1985, 28 days after the submission was received.
What is the product code of K854114?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.