The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steritec Green Card Pack Bowie-dick Test Model Bd 126.
| Device ID | K122945 |
| 510k Number | K122945 |
| Device Name: | STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Contact | Jonathan Rutigliano |
| Correspondent | Jonathan Rutigliano STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2013-04-30 |