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FDA 510(k)

SIGMA PROCEDURE NO. 735

K-Number: K897147 · 1990-04-03

ApplicantSigma Diagnostics, Inc.
Decision Date1990-04-03
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA PROCEDURE NO. 735 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-04-03 under 510(k) number K897147. 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 SIGMA PROCEDURE NO. 735?

SIGMA PROCEDURE NO. 735 is a medical device that received FDA 510(k) clearance on 1990-04-03. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K897147.

When did SIGMA PROCEDURE NO. 735 receive FDA 510(k) clearance?

SIGMA PROCEDURE NO. 735 received FDA 510(k) clearance on 1990-04-03, under 510(k) number K897147.

Who is the listed applicant for SIGMA PROCEDURE NO. 735?

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

What is the FDA product code for SIGMA PROCEDURE NO. 735?

The FDA product code for SIGMA PROCEDURE NO. 735 is KHP.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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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