The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Propper Seracult.
| Device ID | K834297 |
| 510k Number | K834297 |
| Device Name: | PROPPER SERACULT |
| Classification | Reagent, Occult Blood |
| Applicant | PROPPER MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70818087013030 | K834297 | 000 |
| 70818087013023 | K834297 | 000 |
| 70818087013016 | K834297 | 000 |
| 70818087013009 | K834297 | 000 |
| 70818087012989 | K834297 | 000 |
| 30818087013124 | K834297 | 000 |
| 30818087013117 | K834297 | 000 |
| 30818087013100 | K834297 | 000 |
| 30818087012974 | K834297 | 000 |