FDA 510(k)

OXALATE URINE CONTROLS NORMAL & ELEVAT

K-Number: K842366 · 1984-09-12

Decision Date1984-09-12

Product CodeJJW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

OXALATE URINE CONTROLS NORMAL & ELEVAT 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 1984-09-12 under 510(k) number K842366. 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 OXALATE URINE CONTROLS NORMAL & ELEVAT?

OXALATE URINE CONTROLS NORMAL & ELEVAT is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is Sigma Chemical Co.. The 510(k) number is K842366.

When did OXALATE URINE CONTROLS NORMAL & ELEVAT receive FDA 510(k) clearance?

OXALATE URINE CONTROLS NORMAL & ELEVAT received FDA 510(k) clearance on 1984-09-12, under 510(k) number K842366.

Who is the listed applicant for OXALATE URINE CONTROLS NORMAL & ELEVAT?

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 OXALATE URINE CONTROLS NORMAL & ELEVAT?

The FDA product code for OXALATE URINE CONTROLS NORMAL & ELEVAT is JJW.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: JJW)

K170091UA-Cellular CompleteStreck K110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories Limited K103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa Corporation K072640IRISPEC,CA/CB/CCIris Diagnostics K070848LIQUICHEK 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.