DeviceClearance

STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A— 510(k) K141907

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K141907 for STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A, Substantially Equivalent on 2015-05-29. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant
Nova Biomedical Corporation
Product code
Code CHL
Device class
Class 2
Regulation
21 CFR 862.1120
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walham, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CHL

product code CHL
Death
20
Malfunction
999
Total
1,019

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K141907

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141907.

Data sourced from openFDA. This site is unofficial and independent of the FDA.