Glocyte Automated Cell Counter System
FDA 510(k) K152776 · Advanced Instruments, Inc.
510(k) numberK152776
Submission
- Device name
- Glocyte Automated Cell Counter System
- Applicant
- Advanced Instruments, Inc.
Norwood, MA, US - Received
- September 25, 2015
- Decision date
- May 27, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Glocyte Automated Cell Counter System cleared by the FDA?
Glocyte Automated Cell Counter System (K152776) received a 510(k) decision of Substantially Equivalent on May 27, 2016, 245 days after the submission was received.
What is the product code of K152776?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.