FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER MH009
K Number: K922181
·
Decision Aug 17, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
101
Review Days
101
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Basic Information
- Device Name
- COULTER MH009
- K Number
- K922181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coulter Electronics, Inc.
- Date Received
- May 8, 1992
- Decision Date
- August 17, 1992
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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|---|---|---|---|
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| K923530 | COULTER MULTI-Q-PREP | Oct 14, 1992 | Substantially Equivalent |
| K922704 | COULTER MAXM W/ AUTOLOADER | Jul 27, 1992 | Substantially Equivalent |
| K921567 | COULTER MH017 | Jul 6, 1992 | Substantially Equivalent |
| K912133 | PX COULTER(R) CELL CONTROL | Jul 17, 1991 | Substantially Equivalent |
| K911385 | COULTER(R) MH010 | Jun 17, 1991 | Substantially Equivalent |
| K905771 | COULTER DART AST (GOT) REAGENT | Feb 26, 1991 | Substantially Equivalent |
| K905767 | COULTER DART ALT (GPT) REAGENT | Jan 25, 1991 | Substantially Equivalent |