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FDA 510(k)

INDICARD TEST

K-Number: K964015 · 1997-06-19

ApplicantLitmus Concepts, Inc.
Decision Date1997-06-19
Product CodeMJM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDICARD TEST 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 1997-06-19 under 510(k) number K964015. The device is classified under product code MJM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDICARD TEST?

INDICARD TEST is a medical device that received FDA 510(k) clearance on 1997-06-19. The listed applicant is Litmus Concepts, Inc.. The 510(k) number is K964015.

When did INDICARD TEST receive FDA 510(k) clearance?

INDICARD TEST received FDA 510(k) clearance on 1997-06-19, under 510(k) number K964015.

Who is the listed applicant for INDICARD TEST?

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 INDICARD TEST?

The FDA product code for INDICARD TEST is MJM.

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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.

K962718FEMEXAM TESTCARD

Related Devices (Code: MJM)

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.

K923133AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALISMicroprobe Corp.

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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