CRIT-LINE BLOOD CHAMBER WITH E-BEAM— 510(k) K935958
Substantially EquivalentIn-Line Diagnostics Corp.
FDA 510(k) clearance K935958 for CRIT-LINE BLOOD CHAMBER WITH E-BEAM, Substantially Equivalent on 1995-01-19. Applicant: In-Line Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- In-Line Diagnostics Corp.
- Product code
- Code KOC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riverdale, UT, US
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More clearances from In-Line Diagnostics Corp.
view allAdverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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 K935958
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K935958.
Data sourced from openFDA. This site is unofficial and independent of the FDA.