All Medicus Co., Ltd.
Anyang-si Gyeonggi, KR
All Medicus Co., Ltd. appears in FDA device records in Anyang-si Gyeonggi, KR. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for All Medicus Co., Ltd. between 2005 and 2017. The busiest year on record is 2009, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2009 | 2 |
| 2013 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170241 | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K130657 | LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | |
| K083628 | GLUCODR AUTO SYSTEM | NBW | Substantially Equivalent | |
| K082328 | GLUCODR PLUS SYSTEM, MODEL AGM-3000 | NBW | Substantially Equivalent | |
| K050985 | GLUCODR SUPERSENSOR SYSTEM | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007363438 | 3005664575 | All Medicus Co., Ltd. | No.7102-7107,7402,7403,7406, 140, Beolmal-ro, Anyang-si Gyeonggi 14057 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LFRGlucose Dehydrogenase, Glucose
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- NBWSystem, Test, Blood Glucose, Over The Counter
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