The following data is part of a premarket notification filed by Biocircuits Corp. with the FDA for Biocircuits Ios Prostate Specific Antigen (psa) Test Cartridges, Biocircuits Ios Psa Controls.
| Device ID | K981634 |
| 510k Number | K981634 |
| Device Name: | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| 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 | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-08 |
| Decision Date | 1998-10-13 |
| Summary: | summary |