EPOC BLOOD ANALYSIS SYSTEM— 510(k) K061597
Substantially EquivalentEpocal, Inc.
FDA 510(k) clearance K061597 for EPOC BLOOD ANALYSIS SYSTEM, Substantially Equivalent on 2006-09-27. Applicant: Epocal, Inc.. Device class: 2.
Clearance details
- Applicant
- Epocal, Inc.
- Product code
- Code JGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ottawa, CA
Recent devices under product code JGS
view allMore clearances from Epocal, Inc.
view all- K200107 — epoc Blood Analysis System
- K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
- K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TEST
- K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
- K092849 — BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
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 K061597
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 K061597.
Data sourced from openFDA. This site is unofficial and independent of the FDA.