Company ยท US
Leeco Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1989. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 10 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 |
| JJA | Radio-Labeled Iron Method, Iron (Non-Heme) | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 1989 | K895765 | LEECO PREVIEW(R) EBV (EIA) Leeco Diagnostics, Inc. | KTN |
| Aug 15, 1989 | K894122 | LEECO VIS-DISK STREP-A (EIA) Leeco Diagnostics, Inc. | GTZ |
| Jun 16, 1989 | K891096 | VIS-DISK HCG (EIA) JPL-041M Leeco Diagnostics, Inc. | DHA |
| Jun 16, 1989 | K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M Leeco Diagnostics, Inc. | DHA |
| Sep 13, 1988 | K883269 | PRL-QUANT Leeco Diagnostics, Inc. | CFT |
| Mar 15, 1988 | K880577 | CONCEP-7-BHCG Leeco Diagnostics, Inc. | JHI |
| Feb 11, 1988 | K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 Leeco Diagnostics, Inc. | LCX |
| Mar 10, 1987 | K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 Leeco Diagnostics, Inc. | JHI |
| Feb 3, 1987 | K864170 | LEECO VIS-CUBE STREP A (EIA) Leeco Diagnostics, Inc. | GTZ |
| Jan 9, 1987 | K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 Leeco Diagnostics, Inc. | LCX |
| Dec 15, 1986 | K863933 | VIS-CUBE HCG (EIA) Leeco Diagnostics, Inc. | JHI |
| Sep 16, 1986 | K861354 | RIGHT-DAY OVULATION HOME TEST Leeco Diagnostics, Inc. | CEP |
| Jul 29, 1986 | K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) Leeco Diagnostics, Inc. | JHJ |
| Jul 29, 1986 | K860538 | RIGHT-DAY URINARY LH (EIA) Leeco Diagnostics, Inc. | CEP |
| Jun 13, 1986 | K861945 | LEE-BEAD PROLACTIN (EIA) Leeco Diagnostics, Inc. | CFT |
| May 13, 1986 | K860947 | LEECO-SCREEN, STREP A (EIA) Leeco Diagnostics, Inc. | GTZ |
| Mar 17, 1986 | K860003 | LEECO TESTOSTERONE DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CDZ |
| Jan 13, 1986 | K854837 | LEE-BEAD BETA FSH (EIA) Leeco Diagnostics, Inc. | CGJ |
| Jan 7, 1986 | K854838 | LEE-BEAD BETA LH (EIA) Leeco Diagnostics, Inc. | CEP |
| Oct 22, 1985 | K853977 | BETA-TSH-IRMA Leeco Diagnostics, Inc. | JLW |
| Apr 2, 1985 | K850531 | LEECO CONCEP-7-BHCG EIA Leeco Diagnostics, Inc. | JHI |
| Apr 2, 1985 | K850530 | LEECO CONCEP-7-BHCG IRMA Leeco Diagnostics, Inc. | JHI |
| Mar 4, 1985 | K850201 | LEECO CONCEP-7-BHCG LEIAD II Leeco Diagnostics, Inc. | JHI |
| Feb 6, 1985 | K850056 | LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT Leeco Diagnostics, Inc. | JLS |
| Dec 14, 1984 | K844153 | CONCEP-7-BHCG (EIA) Leeco Diagnostics, Inc. | JHI |
| Sep 28, 1984 | K843384 | LEECO CORTISOL-QUANT Leeco Diagnostics, Inc. | CGR |
| Mar 9, 1984 | K834586 | LEECO E2 QUANT DIAG. TEST KIT Leeco Diagnostics, Inc. | CHP |
| Feb 21, 1984 | K834348 | LEECO T3-QUANT DIAG. KIT Leeco Diagnostics, Inc. | CDP |
| May 9, 1983 | K831208 | IGE-QUANT DIAGNOSTIC TEST KIT Leeco Diagnostics, Inc. | DGC |
| Apr 8, 1983 | K830808 | LEECO T3-RIA DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CDP |
| Apr 8, 1983 | K830785 | LEECO DIG-QUANT DIAG. TEST KIT Leeco Diagnostics, Inc. | |
| Apr 5, 1983 | K830512 | LEECO TESTOSTERONE DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CDZ |
| Sep 30, 1982 | K822575 | LEECO T3% DIAGNOSTIC KIT Leeco Diagnostics, Inc. | KHQ |
| Sep 13, 1982 | K822399 | LEECO T4 QUANT DIAGNOSTICS TEST KIT Leeco Diagnostics, Inc. | CDX |
| Jan 22, 1982 | K820039 | LEECO PRL-QUANT DIAGNOSTIC TEST KIT Leeco Diagnostics, Inc. | CFT |
| Dec 22, 1981 | K813392 | RADIOIMMUNOASSAY FOR HUMAN THYROID Leeco Diagnostics, Inc. | JLW |
| Nov 16, 1981 | K813059 | LEECO TESTO-QUANT DIAG. KIT Leeco Diagnostics, Inc. | CDZ |
| Aug 20, 1981 | K812156 | CONCEP-7-BHCG Leeco Diagnostics, Inc. | JHI |
| Jul 16, 1981 | K811880 | LEECO FERRITIN-QUANT DIAG. TEST KIT Leeco Diagnostics, Inc. | DBF |
| Mar 31, 1981 | K810662 | LEECO LH-QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CEP |
| Mar 27, 1981 | K810663 | LEECO FSH-QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CGJ |
| Feb 10, 1981 | K810232 | LEECO P.A.P. - QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. | JFH |
| Jan 2, 1981 | K803001 | LEECO TESTO-QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CDZ |
| Jun 30, 1980 | K801289 | LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT Leeco Diagnostics, Inc. | LCP |
| Jan 16, 1980 | K792652 | LEECO P.A.P. QUANT. DIAGNOSTIC KIT Leeco Diagnostics, Inc. | JFH |
| Dec 6, 1979 | K792308 | CONCEP-7-BHCG Leeco Diagnostics, Inc. | JHI |
| Jun 28, 1979 | K791103 | LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT Leeco Diagnostics, Inc. | LCP |
| May 23, 1979 | K790397 | CONCEP-7-B-HCG Leeco Diagnostics, Inc. | JHI |
| Feb 1, 1979 | K782159 | DIAGNOSTIC KIT, FERRITAB-FE-59 Leeco Diagnostics, Inc. | JJA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||