Infopia Co, Ltd.
Anyang Kvunggi, KR
Infopia Co, Ltd. appears in FDA device records in Anyang Kvunggi, KR. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Infopia Co, Ltd. between 2005 and 2016. The busiest year on record is 2013, with 4. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 4 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K150274 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K141750 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | LCP | Substantially Equivalent | |
| K132406 | ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K133045 | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K132862 | HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K132966 | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K130181 | GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K130295 | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. | NBW | Substantially Equivalent | |
| K121366 | HEMOCUE HBA1C 501 | LCP | Substantially Equivalent | |
| K113192 | HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K113670 | ELEMENT BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K103021 | ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K091168 | GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 | NBW | Substantially Equivalent | |
| K082275 | CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 | LCP | Substantially Equivalent | |
| K090405 | LIPIDPRO SYSTEM | NBW | Substantially Equivalent | |
| K091157 | GLUCO LAB AUTO CODING, MODEL IGM-0022 | NBW | Substantially Equivalent | |
| K090712 | EOCENE SYSTEM | NBW | Substantially Equivalent | |
| K082020 | ENVISION BLOOD GLUCOSE TEST SYSTEM | NBW | Substantially Equivalent | |
| K051285 | GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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