Leeco Diagnostics, Inc.
Mchenry, IL, US
Leeco Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 49 510(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
- 49
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 49 510(k) clearances for Leeco Diagnostics, Inc. between 1979 and 1989. The busiest year on record is 1986, with 9. The most recent is 1989, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 4 |
| 1980 | 2 |
| 1981 | 8 |
| 1982 | 3 |
| 1983 | 4 |
| 1984 | 4 |
| 1985 | 5 |
| 1986 | 9 |
| 1987 | 3 |
| 1988 | 3 |
| 1989 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K895765 | LEECO PREVIEW(R) EBV (EIA) | KTN | Substantially Equivalent | |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | GTZ | Substantially Equivalent | |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | DHA | Substantially Equivalent | |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | DHA | Substantially Equivalent | |
| K883269 | PRL-QUANT | CFT | Substantially Equivalent | |
| K880577 | CONCEP-7-BHCG | JHI | Substantially Equivalent | |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | LCX | Substantially Equivalent | |
| K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 | JHI | Substantially Equivalent | |
| K864170 | LEECO VIS-CUBE STREP A (EIA) | GTZ | Substantially Equivalent | |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | LCX | Substantially Equivalent | |
| K863933 | VIS-CUBE HCG (EIA) | JHI | Substantially Equivalent | |
| K861354 | RIGHT-DAY OVULATION HOME TEST | CEP | Substantially Equivalent | |
| K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) | JHJ | Substantially Equivalent | |
| K860538 | RIGHT-DAY URINARY LH (EIA) | CEP | Substantially Equivalent | |
| K861945 | LEE-BEAD PROLACTIN (EIA) | CFT | Substantially Equivalent | |
| K860947 | LEECO-SCREEN, STREP A (EIA) | GTZ | Substantially Equivalent | |
| K860003 | LEECO TESTOSTERONE DIAGNOSTIC KIT | CDZ | Substantially Equivalent | |
| K854837 | LEE-BEAD BETA FSH (EIA) | CGJ | Substantially Equivalent | |
| K854838 | LEE-BEAD BETA LH (EIA) | CEP | Substantially Equivalent | |
| K853977 | BETA-TSH-IRMA | JLW | Substantially Equivalent | |
| K850531 | LEECO CONCEP-7-BHCG EIA | JHI | Substantially Equivalent | |
| K850530 | LEECO CONCEP-7-BHCG IRMA | JHI | Substantially Equivalent | |
| K850201 | LEECO CONCEP-7-BHCG LEIAD II | JHI | Substantially Equivalent | |
| K850056 | LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT | JLS | Substantially Equivalent | |
| K844153 | CONCEP-7-BHCG (EIA) | JHI | Substantially Equivalent | |
| K843384 | LEECO CORTISOL-QUANT | CGR | Substantially Equivalent | |
| K834586 | LEECO E2 QUANT DIAG. TEST KIT | CHP | Substantially Equivalent | |
| K834348 | LEECO T3-QUANT DIAG. KIT | CDP | Substantially Equivalent | |
| K831208 | IGE-QUANT DIAGNOSTIC TEST KIT | DGC | Substantially Equivalent | |
| K830808 | LEECO T3-RIA DIAGNOSTIC KIT | CDP | Substantially Equivalent | |
| K830785 | LEECO DIG-QUANT DIAG. TEST KIT | Substantially Equivalent | ||
| K830512 | LEECO TESTOSTERONE DIAGNOSTIC KIT | CDZ | Substantially Equivalent | |
| K822575 | LEECO T3% DIAGNOSTIC KIT | KHQ | Substantially Equivalent | |
| K822399 | LEECO T4 QUANT DIAGNOSTICS TEST KIT | CDX | Substantially Equivalent | |
| K820039 | LEECO PRL-QUANT DIAGNOSTIC TEST KIT | CFT | Substantially Equivalent | |
| K813392 | RADIOIMMUNOASSAY FOR HUMAN THYROID | JLW | Substantially Equivalent | |
| K813059 | LEECO TESTO-QUANT DIAG. KIT | CDZ | Substantially Equivalent | |
| K812156 | CONCEP-7-BHCG | JHI | Substantially Equivalent | |
| K811880 | LEECO FERRITIN-QUANT DIAG. TEST KIT | DBF | Substantially Equivalent | |
| K810662 | LEECO LH-QUANT DIAGNOSTIC KIT | CEP | Substantially Equivalent | |
| K810663 | LEECO FSH-QUANT DIAGNOSTIC KIT | CGJ | Substantially Equivalent | |
| K810232 | LEECO P.A.P. - QUANT DIAGNOSTIC KIT | JFH | Substantially Equivalent | |
| K803001 | LEECO TESTO-QUANT DIAGNOSTIC KIT | CDZ | Substantially Equivalent | |
| K801289 | LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT | LCP | Substantially Equivalent | |
| K792652 | LEECO P.A.P. QUANT. DIAGNOSTIC KIT | JFH | Substantially Equivalent | |
| K792308 | CONCEP-7-BHCG | JHI | Substantially Equivalent | |
| K791103 | LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT | LCP | Substantially Equivalent | |
| K790397 | CONCEP-7-B-HCG | JHI | Substantially Equivalent | |
| K782159 | DIAGNOSTIC KIT, FERRITAB-FE-59 | JJA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GTZAntisera, All Groups, Streptococcus Spp.
- LCPAssay, Glycosylated Hemoglobin
- DBFFerritin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JJARadio-Labeled Iron Method, Iron (Non-Heme)
- KHQRadioassay, Triiodothyronine Uptake
- CGRRadioimmunoassay, Cortisol
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- JHIVisual, Pregnancy Hcg, Prescription Use
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