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FDA 510(k)

SIGMA DIAGNOSTICS ELECTROLYTE BUFFER

K-Number: K963540 · 1996-09-27

ApplicantSigma Diagnostics, Inc.
Decision Date1996-09-27
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS ELECTROLYTE BUFFER 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 1996-09-27 under 510(k) number K963540. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS ELECTROLYTE BUFFER?

SIGMA DIAGNOSTICS ELECTROLYTE BUFFER is a medical device that received FDA 510(k) clearance on 1996-09-27. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K963540.

When did SIGMA DIAGNOSTICS ELECTROLYTE BUFFER receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS ELECTROLYTE BUFFER received FDA 510(k) clearance on 1996-09-27, under 510(k) number K963540.

Who is the listed applicant for SIGMA DIAGNOSTICS ELECTROLYTE BUFFER?

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 DIAGNOSTICS ELECTROLYTE BUFFER?

The FDA product code for SIGMA DIAGNOSTICS ELECTROLYTE BUFFER is JFL.

Related Clinical Trials

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.

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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

View all 164 devices →

Related Devices (Code: JFL)

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.

K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K040975GENCHEM CO2 ACID REAGENTGenchem, Inc.K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc.K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTSigma Diagnostics, Inc.K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.K963005NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)Nova Biomedical Corp.

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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