BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS— 510(k) K961566
Substantially EquivalentBiocircuits Corp.
FDA 510(k) clearance K961566 for BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS, Substantially Equivalent on 1996-11-18. Applicant: Biocircuits Corp.. Device class: 2.
Clearance details
- Applicant
- Biocircuits Corp.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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- K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
More 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
- K961792 — BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
- K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
Adverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
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.