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FDA 510(k)

ASSURE URINE HCG CONTROL

K-Number: K941130 · 1994-06-03

ApplicantQuantimetrix Corp.
Decision Date1994-06-03
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSURE URINE HCG CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 1994-06-03 under 510(k) number K941130. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSURE URINE HCG CONTROL?

ASSURE URINE HCG CONTROL is a medical device that received FDA 510(k) clearance on 1994-06-03. The listed applicant is Quantimetrix Corp.. The 510(k) number is K941130.

When did ASSURE URINE HCG CONTROL receive FDA 510(k) clearance?

ASSURE URINE HCG CONTROL received FDA 510(k) clearance on 1994-06-03, under 510(k) number K941130.

Who is the listed applicant for ASSURE URINE HCG CONTROL?

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

What is the FDA product code for ASSURE URINE HCG CONTROL?

The FDA product code for ASSURE URINE HCG CONTROL is JJX.

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Other records listing Quantimetrix Corp. 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.

K113177COMPLETE D 25-OH VITAMIN D CONTROLK103744DROPPER A1C DIABETES CONTROLK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLK062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROL

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Related Devices (Code: JJX)

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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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