The following data is part of a premarket notification filed by Royal Scientific, Inc. with the FDA for Culture Swab.
| Device ID | K780713 |
| 510k Number | K780713 |
| Device Name: | CULTURE SWAB |
| Classification | Antisera, Fluorescent, B. Parapertussis |
| Applicant | ROYAL SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JRW |
| CFR Regulation Number | 866.3065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-27 |
| Decision Date | 1978-05-12 |