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 |
|---|---|---|---|
| Oct 29, 1998 | K981497 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS Steritec Products Mfg Co, Inc. | FRC |
| Jan 9, 1998 | K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) Propper Mfg. Co., Inc. | FRC |
| May 22, 1997 | K971430 | PROSPORE II Raven Biological Laboratories, Inc. | FRC |
| May 20, 1997 | K971432 | PROSPORE Raven Biological Laboratories, Inc. | FRC |
| Mar 4, 1997 | K930683 | EZTEST-GAS Sgm Biomedical, Inc. | FRC |
| Feb 25, 1997 | K963841 | EZTEST Sgm Biotech, Inc. | FRC |
| Sep 18, 1996 | K962441 | PROSPORE(STEARO FOR STEAM STERILIZER) Raven Biological Laboratories, Inc. | FRC |
| Aug 23, 1996 | K961721 | STERITEC DISPOSABLE BIOLOGICAL TEST PACK Steritec Products Mfg Co, Inc. | FRC |
| Aug 16, 1996 | K960790 | PROSPORE II Raven Biological Laboratories, Inc. | FRC |
| May 23, 1996 | K960777 | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR Mdt Corp., Inc. | FRC |
| Mar 31, 1995 | K926364 | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X 3M Health Care, Ltd. | FRC |
| Dec 22, 1994 | K923739 | ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR Abtox, Inc. | FRC |
| Apr 4, 1994 | K930682 | EZTEST-STEAM Sgm Biotech, Inc. | FRC |
| Feb 1, 1994 | K925745 | ATI(R) DISP BIOLOGICAL-PLUS TEST PACK Pymah Corp. | FRC |
| Feb 1, 1994 | K925496 | ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK Pymah Corp. | FRC |
| Oct 1, 1993 | K921909 | STERRAD BI TEST PACK Johnson & Johnson Medical, Inc. | FRC |
| Aug 10, 1992 | K922212 | MDT CASTLE BIOSIGN TEST PACK Mdt Corp., Inc. | FRC |
| Apr 2, 1992 | K912796 | SPORE STRIP Raven Biological Laboratories, Inc. | FRC |
| Mar 27, 1992 | K905425 | SPORVIEW Spsmedical Supply Corp. | FRC |
| Mar 8, 1991 | K910417 | EVIDENCE BIOLOGICAL INDICATOR Skyland Scientific Services, Inc. | FRC |
| Sep 12, 1990 | K903024 | BI-O.K. STEAM TEST-PAK Propper Mfg. Co., Inc. | FRC |
| Jul 19, 1990 | K902344 | ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER Ati | FRC |
| Jul 3, 1990 | K900771 | ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR 3M Company | FRC |
| Mar 8, 1990 | K895704 | ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE Pymah Corp., Ati Div. | FRC |
| Feb 9, 1990 | K891784 | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR Propper Mfg. Co., Inc. | FRC |
| Nov 17, 1989 | K890754 | SPORVIEW CULTURE MEDIA Spsmedical Supply Corp. | FRC |
| Sep 11, 1989 | K894399 | STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI. Pymah Corp. | FRC |
| Sep 11, 1989 | K894398 | STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE Pymah Corp. | FRC |
| Mar 29, 1989 | K891366 | BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) Mdt Corp., Inc. | FRC |
| Jan 19, 1989 | K884615 | ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK Pymah Corp., Ati Div. | FRC |
| Jan 10, 1989 | K884767 | ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK Pymah Corp., Ati Div. | FRC |
| Jul 6, 1988 | K872867 | BIOSIGN Clinical Technology Corp. | FRC |
| Dec 17, 1986 | K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. Surgicot, Inc. | FRC |
| Jul 17, 1986 | K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR Surgicot, Inc. | FRC |
| Jun 18, 1986 | K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK Parke-Davis Co. | FRC |
| May 27, 1986 | K854631 | ASSERT EO BIOLOGICAL TEST PACK Surgicot, Inc. | FRC |
| May 20, 1986 | K854902 | SURGICOT STEAM TEST PACK Surgicot, Inc. | FRC |
| Nov 25, 1985 | K844479 | CHEMSPOR American Sterilizer Co. | FRC |
| Nov 1, 1985 | K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK Parke-Davis Co. | FRC |
| Jun 17, 1985 | K850144 | BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH American Sterilizer Co. | FRC |
| Oct 2, 1984 | K841709 | 48 HOUR BIOLOGICAL INDICATORS SPORSTRIP Skyland Scientific Services, Inc. | FRC |
| May 25, 1984 | K841583 | SPORSTRIP Skyland Scientific Services, Inc. | FRC |
| Nov 21, 1983 | K832922 | TRAVASPORE BIOLOGICAL INDICATOR Travenol Laboratories, S.A. | FRC |
| Jul 22, 1982 | K822024 | BACILLU S SUBTILIS BIOLOGICAL INDICA. Findley Research, Inc. | FRC |
| Sep 8, 1981 | K812272 | CASTLE TEC-TEST BIOLOGICAL INDICATOR Sybron Corp. | FRC |
| Jun 16, 1981 | K810930 | BACILLUM PUMILUS SPORE STRIPS Oxoid U.S.A., Inc. | FRC |
| Dec 9, 1980 | K802228 | BIOLOGICAL INDICATOR - KEMMED & BIOSURE Kem Medical Products Corp. | FRC |
| Aug 13, 1980 | K801678 | SPOR-TEST-STRIP Sterilization Technical Services, Inc. | FRC |
| Apr 16, 1980 | K800482 | STEAROTHERMOHILUS SPORE STRIPS Mdt Corp., Inc. | FRC |
| Mar 12, 1980 | K800029 | SURGICOT 2 INDICATOR SYSTEM Surgicot, Inc. | FRC |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.