FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILTER SAMPLER BLOOD SERUM FILTER
K Number: K771985
·
Decision Nov 2, 1977
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
38
Applicant Total
1
Review Days
14
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
- FILTER SAMPLER BLOOD SERUM FILTER
- K Number
- K771985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clasrock
- Date Received
- October 19, 1977
- Decision Date
- November 2, 1977
- Product Code
- GIM
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| GIM | Tubes, Vacuum Sample, With Anticoagulant | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIM), ordered by most recent decision date.
BD Vacutainer® Citrate Blood Collection Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TransFix/EDTA Vacuum Blood Collection Tubes
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CYTO-CHEX BCT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DS30 HCY BLOOD COLLECTION TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry