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FDA 510(k)

QUANTITATIVE CONTROL URINE II (HUMAN)

K-Number: K792376 · 1979-12-06

ApplicantEnvironmental Chemical Specialties
Decision Date1979-12-06
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE CONTROL URINE II (HUMAN) is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Chemical Specialties. It received FDA 510(k) clearance on 1979-12-06 under 510(k) number K792376. 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 QUANTITATIVE CONTROL URINE II (HUMAN)?

QUANTITATIVE CONTROL URINE II (HUMAN) is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Environmental Chemical Specialties. The 510(k) number is K792376.

When did QUANTITATIVE CONTROL URINE II (HUMAN) receive FDA 510(k) clearance?

QUANTITATIVE CONTROL URINE II (HUMAN) received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792376.

Who is the listed applicant for QUANTITATIVE CONTROL URINE II (HUMAN)?

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

What is the FDA product code for QUANTITATIVE CONTROL URINE II (HUMAN)?

The FDA product code for QUANTITATIVE CONTROL URINE II (HUMAN) is JJW.

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Other records listing Environmental Chemical Specialties 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.

K812635ANEMIA CONTROLK811810URIC ACID TESTK811811TDM ANTI-CONVULSANT CONTROL LEVELS I-IIK811809ANTI-ARRHYTHMIC CONTROL LEVELS I & IIK803089GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)K792377CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL

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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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