FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Glocyte Automated Cell Counter System
K Number: K152776
·
Decision May 27, 2016
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
16
Review Days
245
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Basic Information
- Device Name
- Glocyte Automated Cell Counter System
- K Number
- K152776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Instruments, Inc.
- Date Received
- September 25, 2015
- Decision Date
- May 27, 2016
- Product Code
- GKL
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | Hematology |
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Other Clearances by Advanced Instruments, Inc.
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|---|---|---|---|
| K120631 | PATIENT MONITOR | May 25, 2012 | Substantially Equivalent |
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| K962056 | ADVANCED MICRO-OSMOMETER MODEL 3300 | Jul 11, 1996 | Substantially Equivalent |
| K930526 | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 | Nov 18, 1993 | Substantially Equivalent |
| K925970 | MODEL 3D3 OSMOMETER | Jul 9, 1993 | Substantially Equivalent |
| K911092 | OSMOMETER MODEL 2400 | May 22, 1991 | Substantially Equivalent |
| K873642 | OSMOMETER MODEL 110 | Oct 20, 1987 | Substantially Equivalent |
| K863516 | ELECTRONIC METAL LOCATOR MODEL MD-1 | Sep 30, 1986 | Substantially Equivalent |
| K842784 | CEREGROTRAC | Jan 10, 1985 | Substantially Equivalent |