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FDA 510(k)

ACCESS CHLAMYDIA ASSAY

K-Number: K960850 · 1997-02-04

ApplicantBio-Rad Laboratories, Inc.
Decision Date1997-02-04
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCESS CHLAMYDIA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K960850. 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 ACCESS CHLAMYDIA ASSAY?

ACCESS CHLAMYDIA ASSAY is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K960850.

When did ACCESS CHLAMYDIA ASSAY receive FDA 510(k) clearance?

ACCESS CHLAMYDIA ASSAY received FDA 510(k) clearance on 1997-02-04, under 510(k) number K960850.

Who is the listed applicant for ACCESS CHLAMYDIA ASSAY?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCESS CHLAMYDIA ASSAY?

The FDA product code for ACCESS CHLAMYDIA ASSAY is LJC.

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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.

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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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