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FDA 510(k)

ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA

K-Number: K901972 · 1990-09-05

ApplicantNovo Nordisk Diagnostics, Ltd.
Decision Date1990-09-05
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk Diagnostics, Ltd.. It received FDA 510(k) clearance on 1990-09-05 under 510(k) number K901972. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA?

ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA is a medical device that received FDA 510(k) clearance on 1990-09-05. The listed applicant is Novo Nordisk Diagnostics, Ltd.. The 510(k) number is K901972.

When did ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA receive FDA 510(k) clearance?

ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA received FDA 510(k) clearance on 1990-09-05, under 510(k) number K901972.

Who is the listed applicant for ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA?

The FDA 510(k) record lists Novo Nordisk Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA?

The FDA product code for ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA is LJC.

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Other records listing Novo Nordisk Diagnostics, Ltd. 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.

K911430IDEIA(TM) CHLAMYDIA, MODIFICATION

Related Devices (Code: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, Inc.

Official Source

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