I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2— 510(k) K120900
Substantially EquivalentCliniqa Corporation
FDA 510(k) clearance K120900 for I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2, Substantially Equivalent on 2013-05-31. Applicant: Cliniqa Corporation. Device class: 2.
Clearance details
- Applicant
- Cliniqa Corporation
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Marcos, CA, US
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More clearances from Cliniqa Corporation
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- K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
- K082107 — CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
- K080973 — CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
Data sourced from openFDA. This site is unofficial and independent of the FDA.