FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VON WILLEBRAND REAGENT
K Number: K972116
·
Decision Jul 25, 1997
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
145
Review Days
50
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
- VON WILLEBRAND REAGENT
- K Number
- K972116
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Behring Diagnostics, Inc.
- Date Received
- June 5, 1997
- Decision Date
- July 25, 1997
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGP), ordered by most recent decision date.
CRYOcheck Chromogenic Factor VIII
FDA 510(k)
FDA Class 2
·Hematology
HemosIL Chromogenic Factor IX
FDA 510(k)
FDA Class 2
·Hematology
vWF Ag
FDA 510(k)
FDA Class 2
·Hematology
CRYOcheck Chromogenic Factor IX
FDA 510(k)
FDA Class 2
·Hematology
HemosIL von Willebrand Factor Antigen
FDA 510(k)
FDA Class 2
·Hematology
HemosIL von Willebrand Factor Antigen
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Behring Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973832 | OPUS HLH CONTROLS | Oct 27, 1997 | Substantially Equivalent |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | Oct 20, 1997 | Substantially Equivalent |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | Oct 17, 1997 | Substantially Equivalent |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Sep 12, 1997 | Substantially Equivalent |
| K972316 | OPUS D-DIMER | Sep 9, 1997 | Substantially Equivalent |
| K972011 | OPUS ETHANOL | Jul 22, 1997 | Substantially Equivalent |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | Jun 25, 1997 | Substantially Equivalent |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | Jun 25, 1997 | Substantially Equivalent |
| K964595 | OPUS PSA TEST SYSTEM | Jun 24, 1997 | Substantially Equivalent |
| K971725 | OPUS PROGESTERONE | Jun 18, 1997 | Substantially Equivalent |