FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
K Number: K801841
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
56
Review Days
70
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
- FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
- K Number
- K801841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- American Hospital Supply Corp.
- Date Received
- August 1, 1980
- Decision Date
- October 10, 1980
- Product Code
- GHH
- 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 |
|---|---|---|---|
| GHH | Fibrin Split Products | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GHH), ordered by most recent decision date.
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
FDA 510(k)
FDA Class 2
·Hematology
PATHFAST D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
FDA 510(k)
FDA Class 2
·Hematology
TINA-QUANT D-DIMER TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
TRIAGE D-DIMER TEST, MODEL 98100
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by American Hospital Supply Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854739 | AMERICAN STERILE SURGICAL ABSORBENT TOWEL | Dec 27, 1985 | Substantially Equivalent |
| K854759 | AMERICAN STERILE MAYO STAND TRAY | Dec 17, 1985 | Substantially Equivalent |
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | Apr 23, 1984 | Substantially Equivalent |
| K830546 | DOSIMETRIC RELEASE | May 25, 1983 | Substantially Equivalent |
| K822990 | CONVERTORS PRIMARY WOUND DRESSING II | Apr 12, 1983 | Substantially Equivalent |
| K830343 | CONTAINER W/PRIMING SOLUTION | Mar 17, 1983 | Substantially Equivalent |
| K830301 | STRATUS FLUOROMETRIC ENZYME IMMUN0- | Feb 25, 1983 | Substantially Equivalent |
| K822755 | LATEX PENROSE TUBING | Jan 21, 1983 | Substantially Equivalent |
| K823418 | HEYER-SCHUTE UNIVERSAL URETERAL STENT | Dec 3, 1982 | Substantially Equivalent |
| K822966 | CONVERTORS DISPOSABLE DRESSING SPONGE | Nov 5, 1982 | Substantially Equivalent |