ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501— 510(k) K092705
Substantially EquivalentAbbott Molecular, Inc.
FDA 510(k) clearance K092705 for ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501, Substantially Equivalent on 2010-05-28. Applicant: Abbott Molecular, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Molecular, Inc.
- Product code
- Code OOI
- Device class
- Class 2
- Regulation
- 21 CFR 862.2570
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
Recent devices under product code OOI
view allMore clearances from Abbott Molecular, Inc.
view allAdverse events under product code OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
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 K092705
K-number listed on FDA's recall record- Z-0463-2015 — Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
- Z-2169-2014 — 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.
- Z-0948-2015 — The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
- Z-0634-2013 — Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.
- Z-2013-2012 — Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092705.
Data sourced from openFDA. This site is unofficial and independent of the FDA.