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FDA 510(k)

OVEIA (TM) DUAL ANALYTE

K-Number: K872843 · 1988-02-02

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1988-02-02
Product CodeJLP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OVEIA (TM) DUAL ANALYTE 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 1988-02-02 under 510(k) number K872843. The device is classified under product code JLP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVEIA (TM) DUAL ANALYTE?

OVEIA (TM) DUAL ANALYTE is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K872843.

When did OVEIA (TM) DUAL ANALYTE receive FDA 510(k) clearance?

OVEIA (TM) DUAL ANALYTE received FDA 510(k) clearance on 1988-02-02, under 510(k) number K872843.

Who is the listed applicant for OVEIA (TM) DUAL ANALYTE?

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 OVEIA (TM) DUAL ANALYTE?

The FDA product code for OVEIA (TM) DUAL ANALYTE is JLP.

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Other records listing Boots-Celltech Diagnostics, Inc. 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.

K871877IDEIA HERPES SIMPLEX VIRUS TESTK880799MODIFIED IDEIA CHLAMYDIA TESTK880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYK874875CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIK873625CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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