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FDA 510(k)

MICRO21 WITH CEREBROSPINAL FLUID

K-Number: K971470 · 1997-09-16

ApplicantTriangle Biomedical Sciences, Inc.
Decision Date1997-09-16
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICRO21 WITH CEREBROSPINAL FLUID 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 1997-09-16 under 510(k) number K971470. 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 CEREBROSPINAL FLUID?

MICRO21 WITH CEREBROSPINAL FLUID is a medical device that received FDA 510(k) clearance on 1997-09-16. The listed applicant is Triangle Biomedical Sciences, Inc.. The 510(k) number is K971470.

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

MICRO21 WITH CEREBROSPINAL FLUID received FDA 510(k) clearance on 1997-09-16, under 510(k) number K971470.

Who is the listed applicant for MICRO21 WITH CEREBROSPINAL FLUID?

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 CEREBROSPINAL FLUID?

The FDA product code for MICRO21 WITH CEREBROSPINAL FLUID 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.

K982301MICRO21 WITH URINE SEDIMENT ANALYSISK973050MICRO21 WITH WBC ESTIMATEK964165MICRO21 WITH NDNAK960774MICRO21 WITH ANAK960776MICRO21 WITH RETIC

Related Devices (Code: JOY)

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.

K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K221309AI100 with ShonitSigtuple Technologies Pvt. , Ltd.K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision ABK201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc.

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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