FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COULTER MULTI-Q-PREP
K Number: K923530
·
Decision Oct 14, 1992
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
13
Applicant Total
101
Review Days
90
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Basic Information
- Device Name
- COULTER MULTI-Q-PREP
- K Number
- K923530
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.5240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coulter Electronics, Inc.
- Date Received
- July 16, 1992
- Decision Date
- October 14, 1992
- Product Code
- GKH
- 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 |
|---|---|---|---|
| GKH | Apparatus, Automated Blood Cell Diluting | FDA class 1 | Hematology |
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Other Clearances by Coulter Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | Apr 25, 1994 | Substantially Equivalent |
| K930119 | COULTER RETIC-C CELL CONTROL | Apr 5, 1993 | Substantially Equivalent |
| K921279 | CD4 CYTOSPHERES KIT | Dec 29, 1992 | Substantially Equivalent |
| K922181 | COULTER MH009 | Aug 17, 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 |