IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER— 510(k) K970227
Substantially EquivalentDpc Cirrus
FDA 510(k) clearance K970227 for IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER, Substantially Equivalent on 1997-04-08. Applicant: Dpc Cirrus. Device class: 1.
Clearance details
- Applicant
- Dpc Cirrus
- 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
- Randolph, NJ, US
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- K130276 — DIMENSION EXL WITH LM SYSTEM
More clearances from Dpc Cirrus
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 K970227
K-number listed on FDA's recall record- Z-2469-2020 — Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
- Z-2470-2020 — Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
- Z-1658-2015 — Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
- Z-1660-2015 — Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
- Z-1661-2015 — Direct Water feed Kit, Catalog#10373222
- Z-1662-2015 — Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
- Z-1663-2015 — Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
- Z-1832-2014 — VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
- Z-1316-2014 — IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970227.
Data sourced from openFDA. This site is unofficial and independent of the FDA.