FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL
K Number: K844678
·
Decision Jan 4, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
15
Review Days
35
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Basic Information
- Device Name
- MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL
- K Number
- K844678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Meloy Laboratories, Inc.
- Date Received
- November 30, 1984
- Decision Date
- January 4, 1985
- Product Code
- DHN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Meloy Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852033 | SS-A(RO) & SS-B(LA) ANTIBODY ASSAY | Jun 21, 1985 | Substantially Equivalent |
| K841708 | MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII | Jul 19, 1984 | 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 |