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FRC

206 FDA 510(k) clearances · Product code

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RecordFirmDate
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR (K111375)Advanced Sterilization Products2012-09-14
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (K113221)North American Science Assoc., Inc.2012-04-27
SPSMEDICAL SPORVIEW STEAM BI (K111515)Spsmedical Supply Corp.2012-02-01
SMART READ EZTEST STEAM (K112018)Mesa Laboratories, Inc.2012-01-30
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS (K113302)North American Science Assoc., Inc.2012-01-20
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K111150)Steritec Products Mfg Co, Inc.2011-07-08
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER (K103277)3M Company-3M Health Care2011-04-19
STERRAAD 100NX EXPRESS CYCLE TEST PACK (K092755)Advanced Sterilization Products2011-02-25
STERRAD CYCLESURE BIOLOGICAL INDICATOR (K103222)Advanced Sterilization Products2011-02-25
DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES (K103321)Dana Products, Inc.2011-02-16
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR (K102884)Advanced Sterilization Products2011-01-28
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS (K101910)3M Company2010-12-08
SMART-READ EZTEST-STEAM SCBI AND TEST PACK (K093794)Sgm Biotech, Inc.2010-05-14
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION (K092944)Dana Products, Inc.2010-03-18
SMART-WELL EZTEST INCUBATOR (K091950)Sgm Biotech, Inc.2010-01-15
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION (K092906)STERIS Corporation2009-12-30
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR (K082756)Raven Biological Laboratories, Inc.2009-10-21
VERIFY SCBI 275F 3-10 (K083665)STERIS Corporation2009-09-01
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 (K090569)3M Company2009-04-29
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES (K090514)STERIS Corporation2009-03-16
VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK (K073618)STERIS Corporation2009-01-07
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES (K073244)STERIS Corporation2008-05-28
STERRAD 100NX TEST PACK (K071537)Advanced Sterilization Products2007-12-18
SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR (K070595)Spsmedical Supply Corp.2007-05-24
MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR (K071014)Advanced Sterilization Products2007-05-24
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR (K051056)Albert Browne , Ltd.2005-10-20
STERRAD STERILIZER CYCLESURE TEST PACK (K051643)Advanced Sterilization Products2005-08-19
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER (K052128)3M Company2005-08-16
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK (K051173)Spsmedical Supply Corp.2005-05-27
STERRAD NX CHALLENGE PACK (K042450)Advanced Sterilization Products2005-05-12
SPOR-TEST PA BIOLOGICAL INDICATOR KIT (K050664)Getinge USA, Inc.2005-04-07
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS (K050591)Raven Biological Laboratories, Inc.2005-03-23
RAVEN PROTEST - EO (K041784)Raven Biological Laboratories, Inc.2004-09-13
RAVEN PROTEST - STEAM (K041386)Raven Biological Laboratories, Inc.2004-08-09
MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS (K032914)Raven Biological Laboratories, Inc.2004-05-25
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP (K041099)Spsmedical Supply Corp.2004-05-06
ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK (K031012)3M Company2003-10-16
BIOSIGN STEAM-24 BIOLOGICAL INDICATOR (K032723)Getinge USA, Inc.2003-10-01
STERRAD CYCLESURE BIOLOGICAL INDICATOR (K031226)Advanced Sterilization Products2003-05-02
ALIBI BIOLOGICAL INDICATOR, MODEL WS (K024079)Arden Laboratories, Incorporated2003-02-27
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP (K023716)Spsmedical Supply Corp.2002-12-05
SPSMEDICAL SPORVIEW STEAM BI TEST PACK (K022706)Spsmedical Supply Corp.2002-10-25
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT (K020205)Getinge/Castle, Inc.2002-06-24
3M ATTEST 290 AUTO-READER (K004009)3M Company2002-03-25
STERRAD CYCLESURE BIOLOGICAL INDICATOR (K994055)Advanced Sterilization Products2002-02-13
RAVEN BACTERIAL SPORE STRIPS (K020026)Raven Biological Laboratories, Inc.2002-01-30
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR (K994381)Raven Biological Laboratories, Inc.2001-03-30
BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR (K991618)Propper Mfg. Co., Inc.2001-01-24
STERRAD BI TEST PACK (K993775)Advanced Sterilization Products2000-06-01
MODIFICATION OF: STERRAD BI TEST PACK (K991675)Advanced Sterilization Products1999-06-15
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS (K981497)Steritec Products Mfg Co, Inc.1998-10-29
BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) (K972747)Propper Mfg. Co., Inc.1998-01-09
PROSPORE II (K971430)Raven Biological Laboratories, Inc.1997-05-22
PROSPORE (K971432)Raven Biological Laboratories, Inc.1997-05-20
EZTEST-GAS (K930683)Sgm Biomedical, Inc.1997-03-04
EZTEST (K963841)Sgm Biotech, Inc.1997-02-25
PROSPORE(STEARO FOR STEAM STERILIZER) (K962441)Raven Biological Laboratories, Inc.1996-09-18
STERITEC DISPOSABLE BIOLOGICAL TEST PACK (K961721)Steritec Products Mfg Co, Inc.1996-08-23
PROSPORE II (K960790)Raven Biological Laboratories, Inc.1996-08-16
MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR (K960777)Mdt Corp., Inc.1996-05-23
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (K926364)3M Health Care, Ltd.1995-03-31
ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR (K923739)Abtox, Inc.1994-12-22
EZTEST-STEAM (K930682)Sgm Biotech, Inc.1994-04-04
ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK (K925496)Pymah Corp.1994-02-01
ATI(R) DISP BIOLOGICAL-PLUS TEST PACK (K925745)Pymah Corp.1994-02-01
STERRAD BI TEST PACK (K921909)Johnson & Johnson Medical, Inc.1993-10-01
MDT CASTLE BIOSIGN TEST PACK (K922212)Mdt Corp., Inc.1992-08-10
SPORE STRIP (K912796)Raven Biological Laboratories, Inc.1992-04-02
SPORVIEW (K905425)Spsmedical Supply Corp.1992-03-27
EVIDENCE BIOLOGICAL INDICATOR (K910417)Skyland Scientific Services, Inc.1991-03-08
BI-O.K. STEAM TEST-PAK (K903024)Propper Mfg. Co., Inc.1990-09-12
ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER (K902344)Ati1990-07-19
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR (K900771)3M Company1990-07-03
ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE (K895704)Pymah Corp., Ati Div.1990-03-08
BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR (K891784)Propper Mfg. Co., Inc.1990-02-09
SPORVIEW CULTURE MEDIA (K890754)Spsmedical Supply Corp.1989-11-17
STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE (K894398)Pymah Corp.1989-09-11
STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI. (K894399)Pymah Corp.1989-09-11
BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) (K891366)Mdt Corp., Inc.1989-03-29
ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK (K884615)Pymah Corp., Ati Div.1989-01-19
ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK (K884767)Pymah Corp., Ati Div.1989-01-10
BIOSIGN (K872867)Clinical Technology Corp.1988-07-06
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. (K863122)Surgicot, Inc.1986-12-17
ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR (K855101)Surgicot, Inc.1986-07-17
ATI DISPOSABLE BIOLOGICAL TEST PACK (K855120)Parke-Davis Co.1986-06-18
ASSERT EO BIOLOGICAL TEST PACK (K854631)Surgicot, Inc.1986-05-27
SURGICOT STEAM TEST PACK (K854902)Surgicot, Inc.1986-05-20
CHEMSPOR (K844479)American Sterilizer Co.1985-11-25
DISPOSABLE STEAM BIOLOGICAL TEST PACK (K852192)Parke-Davis Co.1985-11-01
BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH (K850144)American Sterilizer Co.1985-06-17
48 HOUR BIOLOGICAL INDICATORS SPORSTRIP (K841709)Skyland Scientific Services, Inc.1984-10-02
SPORSTRIP (K841583)Skyland Scientific Services, Inc.1984-05-25
TRAVASPORE BIOLOGICAL INDICATOR (K832922)Travenol Laboratories, S.A.1983-11-21
BACILLU S SUBTILIS BIOLOGICAL INDICA. (K822024)Findley Research, Inc.1982-07-22
CASTLE TEC-TEST BIOLOGICAL INDICATOR (K812272)Sybron Corp.1981-09-08
BACILLUM PUMILUS SPORE STRIPS (K810930)Oxoid U.S.A., Inc.1981-06-16
BIOLOGICAL INDICATOR - KEMMED & BIOSURE (K802228)Kem Medical Products Corp.1980-12-09
SPOR-TEST-STRIP (K801678)Sterilization Technical Services, Inc.1980-08-13
STEAROTHERMOHILUS SPORE STRIPS (K800482)Mdt Corp., Inc.1980-04-16
SURGICOT 2 INDICATOR SYSTEM (K800029)Surgicot, Inc.1980-03-12
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