FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MELOY AUTOANTIBODY TEST SYS
K Number: K842247
·
Decision Jun 26, 1984
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
26
Applicant Total
15
Review Days
20
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Basic Information
- Device Name
- MELOY AUTOANTIBODY TEST SYS
- K Number
- K842247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Meloy Laboratories, Inc.
- Date Received
- June 6, 1984
- Decision Date
- June 26, 1984
- Product Code
- DBM
- 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 |
|---|---|---|---|
| DBM | Antimitochondrial 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 |
| K844678 | MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL | Jan 4, 1985 | Substantially Equivalent |
| K841708 | MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII | Jul 19, 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 |