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FDA 510(k)

QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)

K-Number: K931761 · 1993-06-22

ApplicantQuidel Corp.
Decision Date1993-06-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K931761. 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 QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)?

QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Quidel Corp.. The 510(k) number is K931761.

When did QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) receive FDA 510(k) clearance?

QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) received FDA 510(k) clearance on 1993-06-22, under 510(k) number K931761.

Who is the listed applicant for QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)?

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

What is the FDA product code for QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)?

The FDA product code for QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) is JJX.

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Other records listing Quidel 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.

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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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