Panels › General Hospital › Product code FRC · Class 2
Indicator, Biological Sterilization Process
Regulation 880.2800
1510(k)s in 12 months (206 all time)
8recalls in 12 months (46 all time)
41recalls that name a 510(k)
Top companies in FRC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2012 | K111375 | STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Apr 27, 2012 | K113221 | NAMSA BIOLOGICAL INDICATOR SPORE STRIPS North American Science Assoc., Inc. | FRC |
| Feb 1, 2012 | K111515 | SPSMEDICAL SPORVIEW STEAM BI Spsmedical Supply Corp. | FRC |
| Jan 30, 2012 | K112018 | SMART READ EZTEST STEAM Mesa Laboratories, Inc. | FRC |
| Jan 20, 2012 | K113302 | NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS North American Science Assoc., Inc. | FRC |
| Jul 8, 2011 | K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR Steritec Products Mfg Co, Inc. | FRC |
| Apr 19, 2011 | K103277 | 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER 3M Company-3M Health Care | FRC |
| Feb 25, 2011 | K103222 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Feb 25, 2011 | K092755 | STERRAAD 100NX EXPRESS CYCLE TEST PACK Advanced Sterilization Products | FRC |
| Feb 16, 2011 | K103321 | DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES Dana Products, Inc. | FRC |
| Jan 28, 2011 | K102884 | STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Dec 8, 2010 | K101910 | 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS 3M Company | FRC |
| May 14, 2010 | K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK Sgm Biotech, Inc. | FRC |
| Mar 18, 2010 | K092944 | DANA REUSABLE TEST PACK FOR STEAM STERILIZATION Dana Products, Inc. | FRC |
| Jan 15, 2010 | K091950 | SMART-WELL EZTEST INCUBATOR Sgm Biotech, Inc. | FRC |
| Dec 30, 2009 | K092906 | VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION STERIS Corporation | FRC |
| Oct 21, 2009 | K082756 | RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR Raven Biological Laboratories, Inc. | FRC |
| Sep 1, 2009 | K083665 | VERIFY SCBI 275F 3-10 STERIS Corporation | FRC |
| Apr 29, 2009 | K090569 | MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 3M Company | FRC |
| Mar 16, 2009 | K090514 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES STERIS Corporation | FRC |
| Jan 7, 2009 | K073618 | VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK STERIS Corporation | FRC |
| May 28, 2008 | K073244 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES STERIS Corporation | FRC |
| Dec 18, 2007 | K071537 | STERRAD 100NX TEST PACK Advanced Sterilization Products | FRC |
| May 24, 2007 | K071014 | MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| May 24, 2007 | K070595 | SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR Spsmedical Supply Corp. | FRC |
| Oct 20, 2005 | K051056 | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR Albert Browne , Ltd. | FRC |
| Aug 19, 2005 | K051643 | STERRAD STERILIZER CYCLESURE TEST PACK Advanced Sterilization Products | FRC |
| Aug 16, 2005 | K052128 | 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER 3M Company | FRC |
| May 27, 2005 | K051173 | SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK Spsmedical Supply Corp. | FRC |
| May 12, 2005 | K042450 | STERRAD NX CHALLENGE PACK Advanced Sterilization Products | FRC |
| Apr 7, 2005 | K050664 | SPOR-TEST PA BIOLOGICAL INDICATOR KIT Getinge USA, Inc. | FRC |
| Mar 23, 2005 | K050591 | MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS Raven Biological Laboratories, Inc. | FRC |
| Sep 13, 2004 | K041784 | RAVEN PROTEST - EO Raven Biological Laboratories, Inc. | FRC |
| Aug 9, 2004 | K041386 | RAVEN PROTEST - STEAM Raven Biological Laboratories, Inc. | FRC |
| May 25, 2004 | K032914 | MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS Raven Biological Laboratories, Inc. | FRC |
| May 6, 2004 | K041099 | MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP Spsmedical Supply Corp. | FRC |
| Oct 16, 2003 | K031012 | ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK 3M Company | FRC |
| Oct 1, 2003 | K032723 | BIOSIGN STEAM-24 BIOLOGICAL INDICATOR Getinge USA, Inc. | FRC |
| May 2, 2003 | K031226 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Feb 27, 2003 | K024079 | ALIBI BIOLOGICAL INDICATOR, MODEL WS Arden Laboratories, Incorporated | FRC |
| Dec 5, 2002 | K023716 | SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP Spsmedical Supply Corp. | FRC |
| Oct 25, 2002 | K022706 | SPSMEDICAL SPORVIEW STEAM BI TEST PACK Spsmedical Supply Corp. | FRC |
| Jun 24, 2002 | K020205 | CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT Getinge/Castle, Inc. | FRC |
| Mar 25, 2002 | K004009 | 3M ATTEST 290 AUTO-READER 3M Company | FRC |
| Feb 13, 2002 | K994055 | STERRAD CYCLESURE BIOLOGICAL INDICATOR Advanced Sterilization Products | FRC |
| Jan 30, 2002 | K020026 | RAVEN BACTERIAL SPORE STRIPS Raven Biological Laboratories, Inc. | FRC |
| Mar 30, 2001 | K994381 | PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR Raven Biological Laboratories, Inc. | FRC |
| Jan 24, 2001 | K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR Propper Mfg. Co., Inc. | FRC |
| Jun 1, 2000 | K993775 | STERRAD BI TEST PACK Advanced Sterilization Products | FRC |
| Jun 15, 1999 | K991675 | MODIFICATION OF: STERRAD BI TEST PACK Advanced Sterilization Products | FRC |
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