FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED BLOOD CELL COUNTING & LYSING
K Number: K801357
·
Decision Aug 14, 1980
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
37
Applicant Total
101
Review Days
66
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Basic Information
- Device Name
- MODIFIED BLOOD CELL COUNTING & LYSING
- K Number
- K801357
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Coulter Electronics, Inc.
- Date Received
- June 9, 1980
- Decision Date
- August 14, 1980
- Product Code
- GIF
- 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 |
|---|---|---|---|
| GIF | Diluent, Blood Cell | FDA class 1 | Hematology |
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|---|---|---|---|
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| K923530 | COULTER MULTI-Q-PREP | Oct 14, 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 |