BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS— 510(k) K981634
Substantially EquivalentBiocircuits Corp.
FDA 510(k) clearance K981634 for BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS, Substantially Equivalent on 1998-10-13. Applicant: Biocircuits Corp..
Clearance details
- Applicant
- Biocircuits Corp.
- Product code
- Code LTJ
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.