FDA 510(k)

BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS

K-Number: K963770 · 1996-12-05

Decision Date1996-12-05

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuits Corp.. It received FDA 510(k) clearance on 1996-12-05 under 510(k) number K963770. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS?

BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS is a medical device that received FDA 510(k) clearance on 1996-12-05. The listed applicant is Biocircuits Corp.. The 510(k) number is K963770.

When did BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS receive FDA 510(k) clearance?

BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS received FDA 510(k) clearance on 1996-12-05, under 510(k) number K963770.

Who is the listed applicant for BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS?

The FDA 510(k) record lists Biocircuits Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS?

The FDA product code for BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS is JJY.

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Other records listing Biocircuits Corp. as applicant

K981634BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS K980819BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS K961566BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS K961792BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)K952751BIOCIRCUITS IOS T4/TU TEST CARTRIDGES

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Related Devices (Code: JJY)

K162530Multichem IA PlusTechno-Path Manufacturing K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad Laboratories K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad Laboratories K132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.