Company ยท US
Meloy Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1985. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 5 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CJQ | Radial Immunodiffusion, Albumin | 1 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 1985 | K852033 | SS-A(RO) & SS-B(LA) ANTIBODY ASSAY Meloy Laboratories, Inc. | DHN |
| Jan 4, 1985 | K844678 | MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL Meloy Laboratories, Inc. | DHN |
| Jul 19, 1984 | K841708 | MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII Meloy Laboratories, Inc. | GGP |
| Jun 26, 1984 | K842247 | MELOY AUTOANTIBODY TEST SYS Meloy Laboratories, Inc. | DBM |
| Jul 18, 1983 | K831292 | ANTI-ENA TEST Meloy Laboratories, Inc. | LKO |
| Feb 12, 1982 | K820265 | ANA TEST (MOUSE LIVER SUBSTRATE) Meloy Laboratories, Inc. | DHN |
| Jan 22, 1982 | K820005 | TOTAL HEMOLYTIC COMPLEMENT TEST KIT Meloy Laboratories, Inc. | |
| May 15, 1981 | K811178 | HUMAN IGG-ALBUMIN TEST KIT Meloy Laboratories, Inc. | CJQ |
| Jan 16, 1980 | K792562 | IMMUNOSTAT TSH TEST Meloy Laboratories, Inc. | JLW |
| Sep 24, 1979 | K791493 | ANTI-NUCLEAR ANTIBODY TEST Meloy Laboratories, Inc. | DHN |
| Jul 30, 1979 | K791065 | IMMUNOSPOT TSH TEST Meloy Laboratories, Inc. | JLW |
| Mar 15, 1979 | K790252 | ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI Meloy Laboratories, Inc. | DHN |
| Sep 15, 1977 | K771606 | IMMUNOSPOT NEONATAL T4 TEST Meloy Laboratories, Inc. | CDX |
| Sep 2, 1977 | K771382 | IMMUNOSTAT T3 UPTAKE TEST Meloy Laboratories, Inc. | |
| Aug 4, 1977 | K771155 | ANTI-MITOCHONDRIAL Meloy Laboratories, Inc. | DBE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||