FDA 510(k)

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X

K-Number: K070848 · 2007-04-25

Decision Date2007-04-25

Product CodeJJW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad, Diagnostics Grp.. It received FDA 510(k) clearance on 2007-04-25 under 510(k) number K070848. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X?

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X is a medical device that received FDA 510(k) clearance on 2007-04-25. The listed applicant is Bio-Rad, Diagnostics Grp.. The 510(k) number is K070848.

When did LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X receive FDA 510(k) clearance?

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X received FDA 510(k) clearance on 2007-04-25, under 510(k) number K070848.

Who is the listed applicant for LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X?

The FDA 510(k) record lists Bio-Rad, Diagnostics Grp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X?

The FDA product code for LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X is JJW.

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Other records listing Bio-Rad, Diagnostics Grp. as applicant

K121794LIQUICHEK URINE CHEMISTRY CONTROL K100727LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK K072835LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK K072721LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC K071319I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

Related Devices (Code: JJW)

K170091UA-Cellular CompleteStreck K110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories Limited K103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa Corporation K072640IRISPEC,CA/CB/CCIris Diagnostics K052242ADVIA CHEMISTRY MICROALBUMIN CONTROLSBayer Healthcare, LLC

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.