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FDA 510(k)

URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100

K-Number: K000874 · 2000-04-18

ApplicantBio-Rad
Decision Date2000-04-18
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2000-04-18 under 510(k) number K000874. 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 URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100?

URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 is a medical device that received FDA 510(k) clearance on 2000-04-18. The listed applicant is Bio-Rad. The 510(k) number is K000874.

When did URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 receive FDA 510(k) clearance?

URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 received FDA 510(k) clearance on 2000-04-18, under 510(k) number K000874.

Who is the listed applicant for URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100?

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

What is the FDA product code for URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100?

The FDA product code for URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 is JJW.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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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