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FDA 510(k)

BIOTROL CHEMISTRY URINE CONTROL

K-Number: K891286 · 1989-04-10

ApplicantBiotrol, USA, Inc.
Decision Date1989-04-10
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL CHEMISTRY URINE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1989-04-10 under 510(k) number K891286. 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 BIOTROL CHEMISTRY URINE CONTROL?

BIOTROL CHEMISTRY URINE CONTROL is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K891286.

When did BIOTROL CHEMISTRY URINE CONTROL receive FDA 510(k) clearance?

BIOTROL CHEMISTRY URINE CONTROL received FDA 510(k) clearance on 1989-04-10, under 510(k) number K891286.

Who is the listed applicant for BIOTROL CHEMISTRY URINE CONTROL?

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

What is the FDA product code for BIOTROL CHEMISTRY URINE CONTROL?

The FDA product code for BIOTROL CHEMISTRY URINE CONTROL is JJW.

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Other records listing Biotrol, USA, Inc. as applicant

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K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTK931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDS

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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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