The following data is part of a premarket notification filed by Biocircuits Corp. with the FDA for Biocircuits Ios Tsh Test Cartridges/thyroid Controls.
| Device ID | K961566 |
| 510k Number | K961566 |
| Device Name: | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| 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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-23 |
| Decision Date | 1996-11-18 |
| Summary: | summary |