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FDA 510(k)

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

K-Number: K082977 · 2009-08-20

ApplicantMk Bio, Inc.
Decision Date2009-08-20
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP is the device name listed in this FDA 510(k) record. The listed applicant is Mk Bio, Inc.. It received FDA 510(k) clearance on 2009-08-20 under 510(k) number K082977. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP?

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP is a medical device that received FDA 510(k) clearance on 2009-08-20. The listed applicant is Mk Bio, Inc.. The 510(k) number is K082977.

When did BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP receive FDA 510(k) clearance?

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP received FDA 510(k) clearance on 2009-08-20, under 510(k) number K082977.

Who is the listed applicant for BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP?

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

What is the FDA product code for BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP?

The FDA product code for BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP is LDJ.

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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

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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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