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FDA 510(k)

URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II

K-Number: K881275 · 1988-05-16

ApplicantFisher Scientific Co., LLC
Decision Date1988-05-16
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II 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 1988-05-16 under 510(k) number K881275. 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 URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II?

URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II is a medical device that received FDA 510(k) clearance on 1988-05-16. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K881275.

When did URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II receive FDA 510(k) clearance?

URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II received FDA 510(k) clearance on 1988-05-16, under 510(k) number K881275.

Who is the listed applicant for URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II?

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 URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II?

The FDA product code for URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II is JJY.

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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 CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTK872916HISTOMATIC SLIDE STAINER, CODE-ON VERSION

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Related Devices (Code: JJY)

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.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit 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 LaboratoriesK153712VK-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 LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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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