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FDA 510(k)

MICRO21 WITH NDNA

K-Number: K964165 · 1997-01-03

ApplicantTriangle Biomedical Sciences, Inc.
Decision Date1997-01-03
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MICRO21 WITH NDNA is the device name listed in this FDA 510(k) record. The listed applicant is Triangle Biomedical Sciences, Inc.. It received FDA 510(k) clearance on 1997-01-03 under 510(k) number K964165. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO21 WITH NDNA?

MICRO21 WITH NDNA is a medical device that received FDA 510(k) clearance on 1997-01-03. The listed applicant is Triangle Biomedical Sciences, Inc.. The 510(k) number is K964165.

When did MICRO21 WITH NDNA receive FDA 510(k) clearance?

MICRO21 WITH NDNA received FDA 510(k) clearance on 1997-01-03, under 510(k) number K964165.

Who is the listed applicant for MICRO21 WITH NDNA?

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

What is the FDA product code for MICRO21 WITH NDNA?

The FDA product code for MICRO21 WITH NDNA is DHN.

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Other records listing Triangle Biomedical Sciences, 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.

K982301MICRO21 WITH URINE SEDIMENT ANALYSISK973050MICRO21 WITH WBC ESTIMATEK971470MICRO21 WITH CEREBROSPINAL FLUIDK960774MICRO21 WITH ANAK960776MICRO21 WITH RETIC

Related Devices (Code: DHN)

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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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