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FDA 510(k)

SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX

K-Number: K960072 · 1997-03-06

ApplicantBiochem Immunosystems (U.S.), Inc.
Decision Date1997-03-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX is the device name listed in this FDA 510(k) record. The listed applicant is Biochem Immunosystems (U.S.), Inc.. It received FDA 510(k) clearance on 1997-03-06 under 510(k) number K960072. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX?

SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX is a medical device that received FDA 510(k) clearance on 1997-03-06. The listed applicant is Biochem Immunosystems (U.S.), Inc.. The 510(k) number is K960072.

When did SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX receive FDA 510(k) clearance?

SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX received FDA 510(k) clearance on 1997-03-06, under 510(k) number K960072.

Who is the listed applicant for SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX?

The FDA 510(k) record lists Biochem Immunosystems (U.S.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX?

The FDA product code for SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX is GKZ.

Related Clinical Trials

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Other records listing Biochem Immunosystems (U.S.), 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.

K971761PERSONALLAB AUTOMATED MICROPLATE ANALYZERK954065BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KITK955102BIODATA TESTOSTERONE MAIA KIT

Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex 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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