FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K Number: K872360
·
Decision Jul 6, 1987
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
149
Review Days
18
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
- DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
- K Number
- K872360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- American Dade
- Date Received
- June 18, 1987
- Decision Date
- July 6, 1987
- 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 Dade
| K Number | Device Name | ||
|---|---|---|---|
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | Oct 20, 1987 | Substantially Equivalent |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 29, 1987 | Substantially Equivalent |
| K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 14, 1987 | Substantially Equivalent |
| K872789 | PARAMAX URINE/CSF CALIBRATOR | Sep 2, 1987 | Substantially Equivalent |
| K872195 | DATA-FI DIMERTEST LATEX ASSAY | Aug 6, 1987 | Substantially Equivalent |
| K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III | Jul 31, 1987 | Substantially Equivalent |
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | Jul 21, 1987 | Substantially Equivalent |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | Jul 9, 1987 | Substantially Equivalent |
| K872050 | PARAMAX CHOLESTEROL REAGENT | Jul 7, 1987 | Substantially Equivalent |
| K870158 | STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. | Mar 19, 1987 | Substantially Equivalent |