The following data is part of a premarket notification filed by Kem Medical Products Corp. with the FDA for Chemical Indicator - Kem Med & Bio Sure.
| Device ID | K802229 |
| 510k Number | K802229 |
| Device Name: | CHEMICAL INDICATOR - KEM MED & BIO SURE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | KEM MEDICAL PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-10 |
| Decision Date | 1980-12-09 |