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FDA 510(k)

CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE

K-Number: K972748 · 1997-08-29

ApplicantQuidel Corp.
Decision Date1997-08-29
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972748. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE?

CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Quidel Corp.. The 510(k) number is K972748.

When did CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE receive FDA 510(k) clearance?

CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972748.

Who is the listed applicant for CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE?

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 CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE?

The FDA product code for CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE is JHI.

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Other records listing Quidel Corp. as applicant

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Related Devices (Code: JHI)

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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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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