BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS— 510(k) K981634

Substantially Equivalent

Biocircuits 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
Download summary PDFView on FDA.gov ↗

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