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FDA 510(k)

URICHEMTRAK LIQUID ASSAYED URINE CONTROL

K-Number: K031441 · 2003-07-01

ApplicantMedical Analysis Systems, Inc.
Decision Date2003-07-01
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URICHEMTRAK LIQUID ASSAYED URINE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 2003-07-01 under 510(k) number K031441. 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 URICHEMTRAK LIQUID ASSAYED URINE CONTROL?

URICHEMTRAK LIQUID ASSAYED URINE CONTROL is a medical device that received FDA 510(k) clearance on 2003-07-01. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K031441.

When did URICHEMTRAK LIQUID ASSAYED URINE CONTROL receive FDA 510(k) clearance?

URICHEMTRAK LIQUID ASSAYED URINE CONTROL received FDA 510(k) clearance on 2003-07-01, under 510(k) number K031441.

Who is the listed applicant for URICHEMTRAK LIQUID ASSAYED URINE CONTROL?

The FDA 510(k) record lists Medical Analysis Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URICHEMTRAK LIQUID ASSAYED URINE CONTROL?

The FDA product code for URICHEMTRAK LIQUID ASSAYED URINE CONTROL is JJW.

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Other records listing Medical Analysis Systems, Inc. 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN 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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