FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY CALIBRATOR S-CAL
K Number: K813375
·
Decision Feb 4, 1982
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
7
Applicant Total
101
Review Days
65
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEMATOLOGY CALIBRATOR S-CAL
- K Number
- K813375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8185
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Coulter Electronics, Inc.
- Date Received
- December 1, 1981
- Decision Date
- February 4, 1982
- Product Code
- KSA
- 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 |
|---|---|---|---|
| KSA | Calibrator For Red-Cell And White-Cell Counting | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KSA), ordered by most recent decision date.
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
FDA 510(k)
FDA Class 2
·Hematology
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
FDA 510(k)
FDA Class 2
·Hematology
TECH-CAL(TM)/MULTIPLE
FDA 510(k)
FDA Class 2
·Hematology
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
FDA 510(k)
FDA Class 2
·Hematology
CBC-CAL/MULTIPLE
FDA 510(k)
FDA Class 2
·Hematology
TRI-COUNT CALIBRATOR
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 |