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FDA 510(k)

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE

K-Number: K883776 · 1989-02-03

ApplicantBtc Corp.
Decision Date1989-02-03
Product CodeLKI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Btc Corp.. It received FDA 510(k) clearance on 1989-02-03 under 510(k) number K883776. The device is classified under product code LKI. It was reviewed by the MI advisory panel. Product code LKI falls under the category of Chemistry, which covers automated chemistry analyzers and related reagents. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE?

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Btc Corp.. The 510(k) number is K883776.

When did BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE receive FDA 510(k) clearance?

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE received FDA 510(k) clearance on 1989-02-03, under 510(k) number K883776.

Who is the listed applicant for BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE?

The FDA 510(k) record lists Btc Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE?

The FDA product code for BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE is LKI. This falls under the Chemistry category.

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Related Devices (Code: LKI)

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.

K914953IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYStellar Bio Systems, Inc.K905531LUPUS(LE)-LATEX TESTImmco Diagnostics, Inc.K894625CHLAMYDIA (LGV-1)Bion Ent., Ltd.K854615MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TESSerono Diagnostics, Inc.K830342CULUTURE SET CHLAMYDIA ISOLATION ANDImmulok, 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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