Company
Steritec Products Mfc. Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE
SteriTec Steam Biological Test Packs with Instant Readout Inte Terminated |
JOJ | K001444 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR
SteriTec Steam Biological Test Packs with Instant Readout Integrat Terminated |
JOJ | K001444 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25
The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed spec Terminated |
FRC | K111150 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639
The Smart-Read Biological Test Pack with Instant Readout Integrator: is desi Terminated |
FRC | K111150 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638
The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed Terminated |
FRC | K111150 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended fo Terminated |
FRC | K930682 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biol Terminated |
FRC | K930682 |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Bio Terminated |
FRC | K930682 |
| Apr 29, 2010 | Steritec Products Mfc. Co., Inc. Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205. Terminated |
JOJ | K972300 |
| Apr 29, 2010 | Steritec Products Mfc. Co., Inc. Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238. Terminated |
JOJ | K024293 K083650 |