FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
4C ABNORMAL LOW-HIGH (8 X 6 M1)
K Number: K760682
·
Decision Oct 8, 1976
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
101
Review Days
18
Basic Information
- Device Name
- 4C ABNORMAL LOW-HIGH (8 X 6 M1)
- K Number
- K760682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- COULTER ELECTRONICS, INC.
- Date Received
- September 20, 1976
- Decision Date
- October 8, 1976
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPK), ordered by most recent decision date.
XN-L CHECK
FDA 510(k)
FDA Class 2
·Hematology
XN CHECK BF
FDA 510(k)
FDA Class 2
·Hematology
XN CHECK
FDA 510(k)
FDA Class 2
·Hematology
BC-5D Hematology Control
FDA 510(k)
FDA Class 2
·Hematology
XN CHECK
FDA 510(k)
FDA Class 2
·Hematology
XN CHECK BF
FDA 510(k)
FDA Class 2
·Hematology
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 |
| 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 |