Biocircuits Corp. · Class II · Cleared Oct 13, 1998
| K-number | K981634 |
| Device name | BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS |
| Applicant | Biocircuits Corp. |
| Product code | LTJ |
| Device class | Class II |
| Decision date | Oct 13, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov