FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
K Number: K852512
·
Decision Sep 17, 1985
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
29
Review Days
97
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
- THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT
- K Number
- K852512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Pacific Hemostasis
- Date Received
- June 12, 1985
- Decision Date
- September 17, 1985
- 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 Pacific Hemostasis
| K Number | Device Name | ||
|---|---|---|---|
| K000679 | THROMBOSTRATE CONTROL PLASMAS | Mar 24, 2000 | Substantially Equivalent |
| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D | Feb 18, 2000 | Substantially Equivalent |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | Sep 3, 1999 | Substantially Equivalent |
| K992279 | HEPARIN CONTROL PLASMA LEVEL 2 | Aug 26, 1999 | Substantially Equivalent |
| K992278 | HEPARIN CONTROL PLASMA LEVEL 1 | Aug 26, 1999 | Substantially Equivalent |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | Jun 21, 1999 | Substantially Equivalent |
| K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | Feb 17, 1999 | Substantially Equivalent |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | Dec 1, 1998 | Substantially Equivalent |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | Dec 1, 1998 | Substantially Equivalent |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | Dec 1, 1998 | Substantially Equivalent |