ELECSYS 2010 ANALYZER— 510(k) K961481
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K961481 for ELECSYS 2010 ANALYZER, Substantially Equivalent on 1996-06-14. Applicant: Boehringer Mannheim Corp.. Device class: 1.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code JJE
- Device class
- Class 1
- Regulation
- 21 CFR 862.2160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code JJE
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- K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K130276 — DIMENSION EXL WITH LM SYSTEM
More clearances from Boehringer Mannheim Corp.
view allAdverse events under product code JJE
product code JJE- Death
- 6
- Injury
- 441
- Malfunction
- 25,011
- Other
- 1
- Total
- 25,459
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 K961481
K-number listed on FDA's recall record- Z-0499-2018 — Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
- Z-0095-2017 — cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.
- Z-1790-2014 — Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961481.
Data sourced from openFDA. This site is unofficial and independent of the FDA.