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FDA 510(k)

MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1

K-Number: K890534 · 1989-03-08

ApplicantFisher Scientific Co., LLC
Decision Date1989-03-08
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1989-03-08 under 510(k) number K890534. 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 MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1?

MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 is a medical device that received FDA 510(k) clearance on 1989-03-08. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K890534.

When did MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 receive FDA 510(k) clearance?

MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 received FDA 510(k) clearance on 1989-03-08, under 510(k) number K890534.

Who is the listed applicant for MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1?

The FDA product code for MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 is JJW.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTK872916HISTOMATIC SLIDE STAINER, CODE-ON VERSION

View all 89 devices →

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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