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.. Device class: 2.
Clearance details
- Applicant
- Biocircuits Corp.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code LTJ
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- K963770 — BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS
- K961566 — BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
- K961792 — BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
- K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.