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FDA 510(k)

ROCHE LACTATE ANALYZER 640

K-Number: K790421 · 1979-05-15

ApplicantRoche Medical Electronics, Inc.
Decision Date1979-05-15
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE LACTATE ANALYZER 640 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Medical Electronics, Inc.. It received FDA 510(k) clearance on 1979-05-15 under 510(k) number K790421. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE LACTATE ANALYZER 640?

ROCHE LACTATE ANALYZER 640 is a medical device that received FDA 510(k) clearance on 1979-05-15. The listed applicant is Roche Medical Electronics, Inc.. The 510(k) number is K790421.

When did ROCHE LACTATE ANALYZER 640 receive FDA 510(k) clearance?

ROCHE LACTATE ANALYZER 640 received FDA 510(k) clearance on 1979-05-15, under 510(k) number K790421.

Who is the listed applicant for ROCHE LACTATE ANALYZER 640?

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

What is the FDA product code for ROCHE LACTATE ANALYZER 640?

The FDA product code for ROCHE LACTATE ANALYZER 640 is KHP.

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Other records listing Roche Medical Electronics, 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.

K791559ROCHE SENSOR ADAPTORK791038FETASONDE UTERINE ACTIVITY MONITORK791037FETASONDE LABOR STATUS DISPLAYK791039FETASONDE FETAL HEART RATE VARIABILITYK791035FETASONDE FETAL ACTIVITY MONITORK791036FETASONDE UTERINE WORK MONITOR

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Related Devices (Code: KHP)

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.

K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, 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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