The following data is part of a premarket notification filed by Remel Co. with the FDA for Bactidrop Acridine Orange.
| Device ID | K920974 |
| 510k Number | K920974 |
| Device Name: | BACTIDROP ACRIDINE ORANGE |
| Classification | Fluorometric, Calcium |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Ann Silvius |
| Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JFO |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1992-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838023743 | K920974 | 000 |