BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS— 510(k) K980819
Substantially EquivalentBiocircuits Corp.
FDA 510(k) clearance K980819 for BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS, Substantially Equivalent on 1998-04-03. Applicant: Biocircuits Corp.. Device class: 2.
Clearance details
- Applicant
- Biocircuits Corp.
- Product code
- Code CEC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1695
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code CEC
view allMore clearances from Biocircuits Corp.
view all- K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA 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
- K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
Adverse events under product code CEC
product code CEC- Malfunction
- 899
- Total
- 899
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.