The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Sporox Test Strips.
| Device ID | K972035 |
| 510k Number | K972035 |
| Device Name: | SPOROX TEST STRIPS |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Contact | Robert C Boguslaski |
| Correspondent | Robert C Boguslaski SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-08-29 |
| Summary: | summary |