BIOCIRCUITS IOS (IN-OFFICE SYSTEM)— 510(k) K952719
Substantially EquivalentBiocircuits Corp.
FDA 510(k) clearance K952719 for BIOCIRCUITS IOS (IN-OFFICE SYSTEM), Substantially Equivalent on 1995-11-22. Applicant: Biocircuits Corp.. Device class: 1.
Clearance details
- Applicant
- Biocircuits Corp.
- Product code
- Code KHO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2560
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code KHO
view allMore clearances from Biocircuits Corp.
view all- K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
- K980819 — BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
- 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
Adverse events under product code KHO
product code KHO- Malfunction
- 1,339
- Total
- 1,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.