FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII
K Number: K841708
·
Decision Jul 19, 1984
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
15
Review Days
87
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
- MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII
- K Number
- K841708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Meloy Laboratories, Inc.
- Date Received
- April 23, 1984
- Decision Date
- July 19, 1984
- 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 Meloy Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852033 | SS-A(RO) & SS-B(LA) ANTIBODY ASSAY | Jun 21, 1985 | Substantially Equivalent |
| K844678 | MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL | Jan 4, 1985 | Substantially Equivalent |
| K842247 | MELOY AUTOANTIBODY TEST SYS | Jun 26, 1984 | Substantially Equivalent |
| K831292 | ANTI-ENA TEST | Jul 18, 1983 | Substantially Equivalent |
| K820265 | ANA TEST (MOUSE LIVER SUBSTRATE) | Feb 12, 1982 | Substantially Equivalent |
| K820005 | TOTAL HEMOLYTIC COMPLEMENT TEST KIT | Jan 22, 1982 | Substantially Equivalent |
| K811178 | HUMAN IGG-ALBUMIN TEST KIT | May 15, 1981 | Substantially Equivalent |
| K792562 | IMMUNOSTAT TSH TEST | Jan 16, 1980 | Substantially Equivalent |
| K791493 | ANTI-NUCLEAR ANTIBODY TEST | Sep 24, 1979 | Substantially Equivalent |
| K791065 | IMMUNOSPOT TSH TEST | Jul 30, 1979 | Substantially Equivalent |