London Diagnostics, Inc.
Eden Prairie, MN, US
London Diagnostics, Inc. appears in FDA device records in Eden Prairie, MN. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for London Diagnostics, Inc. between 1988 and 1991. The busiest year on record is 1990, with 6. The most recent is 1991, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1990 | 6 |
| 1991 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K914835 | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY | CEC | Substantially Equivalent | |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | CDX | Substantially Equivalent | |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | CFL | Substantially Equivalent | |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | CGJ | Substantially Equivalent | |
| K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION | CFT | Substantially Equivalent | |
| K903130 | LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY | CEW | Substantially Equivalent | |
| K903195 | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY | DGC | Substantially Equivalent | |
| K902443 | LUMATAG(TM) LH DIAGNOSTIC KIT | CEP | Substantially Equivalent | |
| K901484 | LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC | JHI | Substantially Equivalent | |
| K901075 | LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. | DBF | Substantially Equivalent | |
| K881443 | LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY | JLW | Substantially Equivalent | |
| K880296 | LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY | CFT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DBFFerritin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain