BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS— 510(k) K963770
Substantially EquivalentBiocircuits Corp.
FDA 510(k) clearance K963770 for BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS, Substantially Equivalent on 1996-12-05. Applicant: Biocircuits Corp.. Device class: 1.
Clearance details
- Applicant
- Biocircuits Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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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
- 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.