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FDA 510(k)

MICRO21 WITH URINE SEDIMENT ANALYSIS

K-Number: K982301 · 1998-08-07

ApplicantTriangle Biomedical Sciences, Inc.
Decision Date1998-08-07
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICRO21 WITH URINE SEDIMENT ANALYSIS 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 1998-08-07 under 510(k) number K982301. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO21 WITH URINE SEDIMENT ANALYSIS?

MICRO21 WITH URINE SEDIMENT ANALYSIS is a medical device that received FDA 510(k) clearance on 1998-08-07. The listed applicant is Triangle Biomedical Sciences, Inc.. The 510(k) number is K982301.

When did MICRO21 WITH URINE SEDIMENT ANALYSIS receive FDA 510(k) clearance?

MICRO21 WITH URINE SEDIMENT ANALYSIS received FDA 510(k) clearance on 1998-08-07, under 510(k) number K982301.

Who is the listed applicant for MICRO21 WITH URINE SEDIMENT ANALYSIS?

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 URINE SEDIMENT ANALYSIS?

The FDA product code for MICRO21 WITH URINE SEDIMENT ANALYSIS is JOY.

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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.

K973050MICRO21 WITH WBC ESTIMATEK971470MICRO21 WITH CEREBROSPINAL FLUIDK964165MICRO21 WITH NDNAK960774MICRO21 WITH ANAK960776MICRO21 WITH RETIC

Related Devices (Code: JOY)

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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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