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FDA 510(k)

LIQUI-URA CHEMISTRY URINE CONTROLS

K-Number: K840618 · 1984-04-04

ApplicantBiodiagnostic Intl
Decision Date1984-04-04
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUI-URA CHEMISTRY URINE CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Biodiagnostic Intl. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840618. 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 LIQUI-URA CHEMISTRY URINE CONTROLS?

LIQUI-URA CHEMISTRY URINE CONTROLS is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Biodiagnostic Intl. The 510(k) number is K840618.

When did LIQUI-URA CHEMISTRY URINE CONTROLS receive FDA 510(k) clearance?

LIQUI-URA CHEMISTRY URINE CONTROLS received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840618.

Who is the listed applicant for LIQUI-URA CHEMISTRY URINE CONTROLS?

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

What is the FDA product code for LIQUI-URA CHEMISTRY URINE CONTROLS?

The FDA product code for LIQUI-URA CHEMISTRY URINE CONTROLS is JJW.

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Other records listing Biodiagnostic Intl 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.

K031296LIQUI-HEME GLYCO A1C ASSAYK881430LIQUI-SERA SERUM ALCOHOL CONTROLSK874459LIQUI-SERA SPINAL FLUID CONTROLK863849LIQUI-SERA COMBO LIGAND/TDM CONTROLSK853906LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)K853887LIQUI-SERA CHEM. MULTIPLE CALIBRATORS

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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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