The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Propper Super Seracult(r).
| Device ID | K921798 |
| 510k Number | K921798 |
| Device Name: | PROPPER SUPER SERACULT(R) |
| Classification | Reagent, Occult Blood |
| Applicant | PROPPER MFG. CO., INC. 3604 SKILLMAN AVE. Long Island City, NY 11101 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1992-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 70818087013085 | K921798 | 000 |
| 70818087013078 | K921798 | 000 |
| 70818087013061 | K921798 | 000 |
| 70818087013054 | K921798 | 000 |
| 30818087013049 | K921798 | 000 |