The following data is part of a premarket notification filed by Biocircuits Corp. with the FDA for Biocircuits Ios Quantitative Hcg Test Cartridges/biocircuits Ios Immunoassay Controls.
| Device ID | K963770 |
| 510k Number | K963770 |
| Device Name: | BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-19 |
| Decision Date | 1996-12-05 |
| Summary: | summary |