The following data is part of a premarket notification filed by Biocircuits Corp. with the FDA for Biocircuits Ios (in-office System).
| Device ID | K952719 |
| 510k Number | K952719 |
| Device Name: | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) |
| Classification | Fluorometer, For Clinical Use |
| Applicant | BIOCIRCUITS CORP. 1324 CHESAPEAKE TERR. Sunnyvale, CA 94089 |
| Contact | Sheila J Ramerman |
| Correspondent | Sheila J Ramerman BIOCIRCUITS CORP. 1324 CHESAPEAKE TERR. Sunnyvale, CA 94089 |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-15 |
| Decision Date | 1995-11-22 |
| Summary: | summary |