The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Bio-challenge Test Pak.
| Device ID | K851804 |
| 510k Number | K851804 |
| Device Name: | BIO-CHALLENGE TEST PAK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | PROPPER MFG. CO., INC. 3604 SKILLMAN AVE. Long Island City, NY 11101 |
| Contact | John Dyckman |
| Correspondent | John Dyckman PROPPER MFG. CO., INC. 3604 SKILLMAN AVE. Long Island City, NY 11101 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-30 |
| Decision Date | 1985-07-16 |