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FDA 510(k)

QUIDEL CHLAMYDIA TEST

K-Number: K901660 · 1990-07-27

ApplicantQuidel Corp.
Decision Date1990-07-27
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIDEL CHLAMYDIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1990-07-27 under 510(k) number K901660. 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 QUIDEL CHLAMYDIA TEST?

QUIDEL CHLAMYDIA TEST is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is Quidel Corp.. The 510(k) number is K901660.

When did QUIDEL CHLAMYDIA TEST receive FDA 510(k) clearance?

QUIDEL CHLAMYDIA TEST received FDA 510(k) clearance on 1990-07-27, under 510(k) number K901660.

Who is the listed applicant for QUIDEL CHLAMYDIA TEST?

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 QUIDEL CHLAMYDIA TEST?

The FDA product code for QUIDEL CHLAMYDIA TEST is LJC.

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Other records listing Quidel Corp. 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.

K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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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

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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