510(k) K001444
- Device
- STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
- Applicant
- STERITEC PRODUCTS, INC.
- 510(k) number
- K001444
- Product code
- JOJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-05-15
- Date received
- 2000-05-08
- Regulation
- 880.2800
- Classification name
- Indicator, Physical/chemical Sterilization Process
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA NELSON
- Address
- 599 Topeka Way, Suite 700 Castle Rock CO US 80104 80104
FDA Registration Numbers#
- 3004970050
- 3021013267
- 9680887
- 3038718579
- 2132509
- 3021361802
- 3042191618
- 2150060
- 3030626857
- 1833387
- 3004215117
- 2431166
- 2024980
- 3038138452
- 3005558160
- 3010363542
- 2030616
- 3017910185
- 1923569
- 3013145340
- 2434982
- 3007539307
- 3009219448
- 3009609218
- 2432141
- 3004193466
- 3018047916
- 1450386
- 3004201548
- 2084725
- 3001124136
- 3003476474
- 3015895045
- 2437780
- 3013575574
- 3010598169
- 3036504234
- 3034286426
- 3008559238
- 3013187142
- 3029802606
- 9616872
- 1836161
- 3043226252
- 2183785
- 8030087
- 3007620861
- 3016678045
- 3012421607
- 2013736
- 2424472
- 3024787345
- 3031982553
- 3038191347
- 3017230778
- 3035856230
- 3024088964
- 3003418325
- 3008255748
- 3030733800
- 3042272797
- 3010147274
- 3003950207
- 3007412809
- 3005698329
- 3021010394
- 3004634710
- 3013557562
- 8021896
- 3013667284
- 9617111
- 2435946
- 1051614
- 2024312
- 2248608
- 3031757047
- 3027234828
- 2183301
- 3017498782
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JOJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | 2026-02-20 |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2025-12-23 |
| K251035 | DISINTEK™ PA Test Strips | Serim Research | 2025-06-03 |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | 2025-05-02 |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | 2025-04-25 |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | 2025-02-20 |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | 2025-01-17 |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | 2024-12-17 |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024-12-04 |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | 2024-10-15 |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation | 2024-09-30 |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | 2024-08-20 |
| K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) | Advanced Sterilization Products, Inc. | 2024-07-05 |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | 2024-06-26 |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | 2024-06-12 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases