BEHRING COAGULATION SYSTEM— 510(k) K970431
Substantially EquivalentBehring Diagnostics, Inc.
FDA 510(k) clearance K970431 for BEHRING COAGULATION SYSTEM, Substantially Equivalent on 1997-05-05. Applicant: Behring Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Behring Diagnostics, Inc.
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code JPA
view allMore clearances from Behring Diagnostics, Inc.
view allAdverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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 K970431
K-number listed on FDA's recall record- Z-1435-2021 — BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
- Z-0825-2016 — BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970431.
Data sourced from openFDA. This site is unofficial and independent of the FDA.