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FDA 510(k)

FEMEXAM TESTCARD

K-Number: K962718 · 1997-02-07

ApplicantLitmus Concepts, Inc.
Decision Date1997-02-07
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FEMEXAM TESTCARD is the device name listed in this FDA 510(k) record. The listed applicant is Litmus Concepts, Inc.. It received FDA 510(k) clearance on 1997-02-07 under 510(k) number K962718. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMEXAM TESTCARD?

FEMEXAM TESTCARD is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is Litmus Concepts, Inc.. The 510(k) number is K962718.

When did FEMEXAM TESTCARD receive FDA 510(k) clearance?

FEMEXAM TESTCARD received FDA 510(k) clearance on 1997-02-07, under 510(k) number K962718.

Who is the listed applicant for FEMEXAM TESTCARD?

The FDA 510(k) record lists Litmus Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMEXAM TESTCARD?

The FDA product code for FEMEXAM TESTCARD is CEN.

Related Clinical Trials

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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Other records listing Litmus Concepts, Inc. 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.

K964015INDICARD TEST

Related Devices (Code: CEN)

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.

K091287VS-SENSE TESTCommon Sense , Ltd.K071100AMNISCREEN HOME DETECTION LINER KITCommon Sense , Ltd.K051727AIMSTICK URINE REAGENT STRIPSGermaine Laboratories, Inc.K040008QUICKVUE ADVANCE PH AND AMINES GLL TESTQuidel Corp.K030650STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONSUridynamics, Inc.K840827KYOTEST 5VKyoto Diagnostics, Inc.

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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