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FDA 510(k)

IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

K-Number: K864998 · 1987-04-20

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1987-04-20
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDEIA(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 1987-04-20 under 510(k) number K864998. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1987-04-20. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K864998.

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

IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT received FDA 510(k) clearance on 1987-04-20, under 510(k) number K864998.

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

The FDA product code for IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT is JSM.

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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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