The following data is part of a premarket notification filed by Biocircuits Corp. with the FDA for Biocircuits Ios Free Thyroxine (ft4) Test Cartridges Biocircuits Ios Controls.
| Device ID | K980819 |
| 510k Number | K980819 |
| Device Name: | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS |
| Classification | Radioimmunoassay, Free Thyroxine |
| 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 | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-04-03 |
| Summary: | summary |