The following data is part of a premarket notification filed by Biocircuits Corp. with the FDA for Biocircuits Ios Serum Pregnancy Test Cartridges/immunoassay Controls.
| Device ID | K961792 |
| 510k Number | K961792 |
| Device Name: | BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS |
| Classification | System, Test, Human Chorionic Gonadotropin |
| 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 | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-08-21 |
| Summary: | summary |