FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLATELET RETENTION (ADHESION) COLUMNS
K Number: K800037
·
Decision Feb 5, 1980
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
7
Review Days
29
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Basic Information
- Device Name
- PLATELET RETENTION (ADHESION) COLUMNS
- K Number
- K800037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6650
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hemometrix
- Date Received
- January 7, 1980
- Decision Date
- February 5, 1980
- Product Code
- JBZ
- 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 |
|---|---|---|---|
| JBZ | Study, Platelet Adhesive | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBZ), ordered by most recent decision date.
LATELET RETENTION COLUMN
FDA 510(k)
FDA Class 2
·Hematology
THROMBO-SCREEN PLATELET ADHESION
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Hemometrix
| K Number | Device Name | ||
|---|---|---|---|
| K792262 | GENTAMICIN LIQUID CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792260 | AMIKACIN LIQUID CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792263 | TOBRAMYCIN CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792264 | TOBRAMYCIN LIQUID CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792261 | GENTAMICIN CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |
| K792259 | AMIKACIN CONTROL SERUM | Dec 18, 1979 | Substantially Equivalent |