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FDA 510(k)

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

K-Number: K862607 · 1986-08-04

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1986-08-04
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K862607. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT?

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K862607.

When did IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT receive FDA 510(k) clearance?

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT received FDA 510(k) clearance on 1986-08-04, under 510(k) number K862607.

Who is the listed applicant for IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT?

The FDA 510(k) record lists Boots-Celltech Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT?

The FDA product code for IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT is LIO.

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Other records listing Boots-Celltech Diagnostics, Inc. as applicant

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Related Devices (Code: LIO)

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.

K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc.K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLCK120846TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLCK103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICEMedical Wire & Equipment Company (Bath), Ltd.K082472VIROCULT, MODEL MW950Medical Wire & Equipment Company (Bath), Ltd.K070062COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USEDiesse Diagnostica Senese S.P.A.

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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