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FDA 510(k)

LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)

K-Number: K880495 · 1988-03-15

ApplicantBio-Rad
Decision Date1988-03-15
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880495. 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 LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)?

LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Bio-Rad. The 510(k) number is K880495.

When did LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) receive FDA 510(k) clearance?

LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880495.

Who is the listed applicant for LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)?

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

What is the FDA product code for LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)?

The FDA product code for LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) is JJW.

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Other records listing Bio-Rad as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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Related Devices (Code: JJW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

Official Source

View on FDA Database →

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

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