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FDA 510(k)

STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER

K-Number: K902028 · 1990-06-20

ApplicantNorfolk Scientific, Inc.
Decision Date1990-06-20
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER is the device name listed in this FDA 510(k) record. The listed applicant is Norfolk Scientific, Inc.. It received FDA 510(k) clearance on 1990-06-20 under 510(k) number K902028. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER?

STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Norfolk Scientific, Inc.. The 510(k) number is K902028.

When did STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER receive FDA 510(k) clearance?

STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER received FDA 510(k) clearance on 1990-06-20, under 510(k) number K902028.

Who is the listed applicant for STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER?

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

What is the FDA product code for STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER?

The FDA product code for STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER is JPI.

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Other records listing Norfolk Scientific, 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.

K890669STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBEK883185SAFECRIT PLASTIC MICROHEMATOCRIT TUBESK881254STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01K870511CHART-TYPE MICRO HEMATOCRIT TUBE READERK864974GENERAL PURPOSE CENTRIFUGEK860172QWIKSPIN (TM)

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Related Devices (Code: JPI)

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.

K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott LaboratoriesK950942CRIT-LINE HEMATOCRIT ALERTIn-Line Diagnostics Corp.K924167CRIT-LINENoninvasive Medical Technology Corp.K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESStatspin TechnologiesK870511CHART-TYPE MICRO HEMATOCRIT TUBE READERNorfolk Scientific, Inc.

Official Source

View on FDA Database →

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

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