FDA 510(k)
Substantially Equivalent
🇺🇸 United States
TOTAL HEMOLYTIC COMPLEMENT TEST KIT
K Number: K820005
·
Decision Jan 22, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
15
Review Days
18
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Basic Information
- Device Name
- TOTAL HEMOLYTIC COMPLEMENT TEST KIT
- K Number
- K820005
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Meloy Laboratories, Inc.
- Date Received
- January 4, 1982
- Decision Date
- January 22, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
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 |
| 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 |
| 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 |