FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BUCK
K Number: K933401
·
Decision Feb 10, 1994
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
2
Review Days
213
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
- THE BUCK
- K Number
- K933401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Implements, Inc.
- Date Received
- July 12, 1993
- Decision Date
- February 10, 1994
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKA), ordered by most recent decision date.
Female Culture Device; Male Culture Device; Transfer Device; Access Device
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Preset and BD A-Line Arterial Blood Collection Syringes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Steripath® Flow Blood Collection System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Medical Implements, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913330 | URINE COLLECTION KIT/DEVICE | Aug 26, 1991 | Substantially Equivalent |