FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINICAPS
K Number: K843361
·
Decision Sep 21, 1984
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
21
Applicant Total
6
Review Days
24
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
- MINICAPS
- K Number
- K843361
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6150
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Medical Technomics, Ltd.
- Date Received
- August 28, 1984
- Decision Date
- September 21, 1984
- Product Code
- GIO
- 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 |
|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIO), ordered by most recent decision date.
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
MONOJECT SAMPLETTE SEPARATOR TUBE
FDA 510(k)
FDA Class 1
·Hematology
TRU-TRAX
FDA 510(k)
FDA Class 1
·Hematology
HEMA(PRO)TEC(TION)
FDA 510(k)
FDA Class 1
·Hematology
CAPILLARY TUBE, BLOOD COLLECTION
FDA 510(k)
FDA Class 1
·Hematology
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Medical Technomics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K844798 | EPPENDORF DILUTER | Jan 7, 1985 | Substantially Equivalent |
| K843608 | CAPILLARY BLOOD COLLECTION TUBE | Nov 30, 1984 | Substantially Equivalent |
| K843607 | LABOPETTOR | Sep 21, 1984 | Substantially Equivalent |
| K843606 | PRECISION DISPENSER | Sep 21, 1984 | Substantially Equivalent |
| K843362 | RINGCAPS | Sep 21, 1984 | Substantially Equivalent |