FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
K Number: K053571
·
Decision Jun 30, 2006
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
4
Review Days
190
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
- MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K Number
- K053571
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7440
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Interlab S.R.L.
- Date Received
- December 22, 2005
- Decision Date
- June 30, 2006
- Product Code
- JBD
- 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 |
|---|---|---|---|
| JBD | System, Analysis, Electrophoretic Hemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBD), ordered by most recent decision date.
INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ACID HEMOGLOBIN KIT
FDA 510(k)
FDA Class 2
·Hematology
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
FDA 510(k)
FDA Class 2
·Hematology
SPIFE ALKALINE HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
FDA 510(k)
FDA Class 2
·Hematology
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
FDA 510(k)
FDA Class 2
·Hematology