FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTO-CHEX BCT
K Number: K080552
·
Decision Jul 31, 2008
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
38
Applicant Total
33
Review Days
154
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
- CYTO-CHEX BCT
- K Number
- K080552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Streck
- Date Received
- February 28, 2008
- Decision Date
- July 31, 2008
- 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
DS30 HCY BLOOD COLLECTION TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Streck
| K Number | Device Name | ||
|---|---|---|---|
| K254166 | MDx-Chex for BCN | Mar 23, 2026 | Substantially Equivalent |
| K231223 | MDx-Chex for BC-GN | Jul 27, 2023 | Substantially Equivalent |
| K231221 | MDx-Chex for BC-GP | Jul 27, 2023 | Substantially Equivalent |
| K170091 | UA-Cellular Complete | Feb 9, 2017 | Substantially Equivalent |
| K160588 | XN CHECK BF | Dec 22, 2016 | Substantially Equivalent |
| K160586 | XN-L CHECK | Dec 22, 2016 | Substantially Equivalent |
| K160585 | XN CAL | Dec 22, 2016 | Substantially Equivalent |
| K160590 | XN CHECK | Dec 22, 2016 | Substantially Equivalent |
| K141957 | XN CHECK BF | Dec 5, 2014 | Substantially Equivalent |
| K141964 | XN CHECK | Dec 5, 2014 | Substantially Equivalent |