The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Peracetic Acid Chemical Indicator.
| Device ID | K052388 |
| 510k Number | K052388 |
| Device Name: | SERIM PERACETIC ACID CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Contact | Patricia A Rupchock |
| Correspondent | Patricia A Rupchock SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-31 |
| Decision Date | 2005-12-01 |
| Summary: | summary |