510(k) K092705 ยท OOI Real Time Nucleic Acid Amplification System
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, May 28, 2010 |
| Received | Sep 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2015 | Abbott Molecular The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. Terminated |
JJH | None listed |
| Nov 25, 2014 | Abbott Molecular Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing. Terminated |
JJH | None listed |
| Aug 8, 2014 | Abbott Molecular 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 pol Terminated |
JJH | None listed |
| Jan 3, 2013 | Abbott Molecular 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; a Terminated |
JJH | None listed |
| Jul 14, 2012 | Abbott Molecular 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 6 Terminated |
JQW | None listed |
| Jan 11, 2012 | Abbott Molecular Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 Terminated |
JJH | None listed |
| Oct 14, 2011 | Abbott Molecular Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des P Terminated |
OOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.