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FDA 510(k)

CRIT-LINE HEMATOCRIT ALERT

K-Number: K950942 · 1995-03-14

ApplicantIn-Line Diagnostics Corp.
Decision Date1995-03-14
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRIT-LINE HEMATOCRIT ALERT is the device name listed in this FDA 510(k) record. The listed applicant is In-Line Diagnostics Corp.. It received FDA 510(k) clearance on 1995-03-14 under 510(k) number K950942. 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 CRIT-LINE HEMATOCRIT ALERT?

CRIT-LINE HEMATOCRIT ALERT is a medical device that received FDA 510(k) clearance on 1995-03-14. The listed applicant is In-Line Diagnostics Corp.. The 510(k) number is K950942.

When did CRIT-LINE HEMATOCRIT ALERT receive FDA 510(k) clearance?

CRIT-LINE HEMATOCRIT ALERT received FDA 510(k) clearance on 1995-03-14, under 510(k) number K950942.

Who is the listed applicant for CRIT-LINE HEMATOCRIT ALERT?

The FDA 510(k) record lists In-Line Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRIT-LINE HEMATOCRIT ALERT?

The FDA product code for CRIT-LINE HEMATOCRIT ALERT is JPI.

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Other records listing In-Line Diagnostics Corp. 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.

K001763CRIT-LINE MONITOR III (CLM III)K992227CRIT-LINE MONITOR III (CLM III)K983551CRIT-SCAN II MONITORK982412MODIFICATION OF CRIT-LINE MONITOR III (CLM III)K972470CRIT-LINE MONITOR (CLMIII)K953875CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)

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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 LaboratoriesK924167CRIT-LINENoninvasive Medical Technology Corp.K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESStatspin TechnologiesK902028STATSPIN 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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