The following data is part of a premarket notification filed by Raven Biological Laboratories, Inc. with the FDA for Pro-pact Peracetic Acid Culture Test Kit, Model C-3pa.
| Device ID | K031114 |
| 510k Number | K031114 |
| Device Name: | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA |
| Classification | Indicator, Biological, Liquid Chemical Sterilization Process |
| Applicant | RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. Omaha, NE 68127 |
| Contact | Wendy Royalty-hann |
| Correspondent | Wendy Royalty-hann RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. Omaha, NE 68127 |
| Product Code | MRB |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-08 |
| Decision Date | 2004-03-03 |