Company · US
OPTI Medical Systems, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2021. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 4 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 |
| GIO | Tube, Collection, Capillary Blood | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2021 | OPTI Medical Systems, Inc OPTI SARS-CoV-2 RT-PCR Test, REF Numbers:
a) 99-57003
b) 99-57004 Open, Classified |
QJR | None listed |
| Oct 18, 2013 | OPTI Medical Systems, Inc Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical
Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sod Terminated |
JJE | K052027 |
| Sep 21, 2012 | OPTI Medical Systems, Inc BP7561 OPTI CCA-TS B-Lac Cassette (25 per box)
Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total Terminated |
CHL | K093280 |
| Jun 14, 2011 | OPTI Medical Systems, Inc OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box).
Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the mea Terminated |
CGZ | K052027 |
| Mar 11, 2010 | OPTI Medical Systems, Inc OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care.
Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blo Terminated |
CGZ | K052027 |
| Aug 14, 2008 | Opti Medical Systems Inc Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l, Terminated |
GIO | None listed |
| Nov 9, 2007 | Opti Medical Systems Inc OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076 Terminated |
JGS | K052027 |