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FDA 510(k)

STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES

K-Number: K903698 · 1990-09-17

ApplicantStatspin Technologies
Decision Date1990-09-17
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Statspin Technologies. It received FDA 510(k) clearance on 1990-09-17 under 510(k) number K903698. 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 MICRO-HEMATOCRIT READER FOR 75MM TUBES?

STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES is a medical device that received FDA 510(k) clearance on 1990-09-17. The listed applicant is Statspin Technologies. The 510(k) number is K903698.

When did STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES receive FDA 510(k) clearance?

STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES received FDA 510(k) clearance on 1990-09-17, under 510(k) number K903698.

Who is the listed applicant for STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES?

The FDA 510(k) record lists Statspin Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES?

The FDA product code for STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES is JPI.

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Other records listing Statspin Technologies 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.

K896206STATSPIN STATSAMPLERK893613STATSPIN MINI-PLASMAK884807LIPOCLEAR LIPEMIA CLEARING REAGENT

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.K902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERNorfolk Scientific, Inc.K870511CHART-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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