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FDA 510(k)

CALTAG CAL-LYSE

K-Number: K965232 · 1997-05-14

ApplicantCaltag Laboratories, Inc.
Decision Date1997-05-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CALTAG CAL-LYSE is the device name listed in this FDA 510(k) record. The listed applicant is Caltag Laboratories, Inc.. It received FDA 510(k) clearance on 1997-05-14 under 510(k) number K965232. 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 CALTAG CAL-LYSE?

CALTAG CAL-LYSE is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Caltag Laboratories, Inc.. The 510(k) number is K965232.

When did CALTAG CAL-LYSE receive FDA 510(k) clearance?

CALTAG CAL-LYSE received FDA 510(k) clearance on 1997-05-14, under 510(k) number K965232.

Who is the listed applicant for CALTAG CAL-LYSE?

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

What is the FDA product code for CALTAG CAL-LYSE?

The FDA product code for CALTAG CAL-LYSE is GKZ.

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Other records listing Caltag Laboratories, 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.

K990641CALTAG FETAL HEMOGLOBIN TESTK964856CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONK963954CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODYK950917CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONK950916CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATIONK951073CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION

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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

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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