Meloy Laboratories, Inc.
Mchenry, IL, US
Meloy Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Meloy Laboratories, Inc. between 1977 and 1985. The busiest year on record is 1977, with 3. The most recent is 1985, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K852033 | SS-A(RO) & SS-B(LA) ANTIBODY ASSAY | DHN | Substantially Equivalent | |
| K844678 | MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL | DHN | Substantially Equivalent | |
| K841708 | MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII | GGP | Substantially Equivalent | |
| K842247 | MELOY AUTOANTIBODY TEST SYS | DBM | Substantially Equivalent | |
| K831292 | ANTI-ENA TEST | LKO | Substantially Equivalent | |
| K820265 | ANA TEST (MOUSE LIVER SUBSTRATE) | DHN | Substantially Equivalent | |
| K820005 | TOTAL HEMOLYTIC COMPLEMENT TEST KIT | Substantially Equivalent | ||
| K811178 | HUMAN IGG-ALBUMIN TEST KIT | CJQ | Substantially Equivalent | |
| K792562 | IMMUNOSTAT TSH TEST | JLW | Substantially Equivalent | |
| K791493 | ANTI-NUCLEAR ANTIBODY TEST | DHN | Substantially Equivalent | |
| K791065 | IMMUNOSPOT TSH TEST | JLW | Substantially Equivalent | |
| K790252 | ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI | DHN | Substantially Equivalent | |
| K771606 | IMMUNOSPOT NEONATAL T4 TEST | CDX | Substantially Equivalent | |
| K771382 | IMMUNOSTAT T3 UPTAKE TEST | Substantially Equivalent | ||
| K771155 | ANTI-MITOCHONDRIAL | DBE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LKOAnti-Rnp Antibody, Antigen And Control
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- CJQRadial Immunodiffusion, Albumin
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- GGPTest, Qualitative And Quantitative Factor Deficiency
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain