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FDA 510(k)

LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)

K-Number: K884424 · 1988-12-15

ApplicantBio-Rad
Decision Date1988-12-15
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1988-12-15 under 510(k) number K884424. 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 ROUTINE URINE CONTROLS 1 & 2 (HUMAN)?

LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) is a medical device that received FDA 510(k) clearance on 1988-12-15. The listed applicant is Bio-Rad. The 510(k) number is K884424.

When did LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) receive FDA 510(k) clearance?

LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) received FDA 510(k) clearance on 1988-12-15, under 510(k) number K884424.

Who is the listed applicant for LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)?

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 ROUTINE URINE CONTROLS 1 & 2 (HUMAN)?

The FDA product code for LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) 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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