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FDA 510(k)

DIRECTIGEN 1-2-3 PREGNANCY CONTROLS

K-Number: K911664 · 1991-05-31

ApplicantQuidel Corp.
Decision Date1991-05-31
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN 1-2-3 PREGNANCY CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1991-05-31 under 510(k) number K911664. 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 DIRECTIGEN 1-2-3 PREGNANCY CONTROLS?

DIRECTIGEN 1-2-3 PREGNANCY CONTROLS is a medical device that received FDA 510(k) clearance on 1991-05-31. The listed applicant is Quidel Corp.. The 510(k) number is K911664.

When did DIRECTIGEN 1-2-3 PREGNANCY CONTROLS receive FDA 510(k) clearance?

DIRECTIGEN 1-2-3 PREGNANCY CONTROLS received FDA 510(k) clearance on 1991-05-31, under 510(k) number K911664.

Who is the listed applicant for DIRECTIGEN 1-2-3 PREGNANCY CONTROLS?

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 DIRECTIGEN 1-2-3 PREGNANCY CONTROLS?

The FDA product code for DIRECTIGEN 1-2-3 PREGNANCY CONTROLS is 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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