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FDA 510(k)

PRODUCT #K3002 KETOTROL-N(URINE CONTROL)

K-Number: K760863 · 1976-11-02

ApplicantSigma Chemical Co.
Decision Date1976-11-02
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRODUCT #K3002 KETOTROL-N(URINE CONTROL) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1976-11-02 under 510(k) number K760863. 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 PRODUCT #K3002 KETOTROL-N(URINE CONTROL)?

PRODUCT #K3002 KETOTROL-N(URINE CONTROL) is a medical device that received FDA 510(k) clearance on 1976-11-02. The listed applicant is Sigma Chemical Co.. The 510(k) number is K760863.

When did PRODUCT #K3002 KETOTROL-N(URINE CONTROL) receive FDA 510(k) clearance?

PRODUCT #K3002 KETOTROL-N(URINE CONTROL) received FDA 510(k) clearance on 1976-11-02, under 510(k) number K760863.

Who is the listed applicant for PRODUCT #K3002 KETOTROL-N(URINE CONTROL)?

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

What is the FDA product code for PRODUCT #K3002 KETOTROL-N(URINE CONTROL)?

The FDA product code for PRODUCT #K3002 KETOTROL-N(URINE CONTROL) is JJW.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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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