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FDA 510(k)

INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL

K-Number: K881111 · 1988-03-30

ApplicantSigma Diagnostics, Inc.
Decision Date1988-03-30
Product CodeLJG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL 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 1988-03-30 under 510(k) number K881111. The device is classified under product code LJG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL?

INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 1988-03-30. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K881111.

When did INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL receive FDA 510(k) clearance?

INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL received FDA 510(k) clearance on 1988-03-30, under 510(k) number K881111.

Who is the listed applicant for INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL?

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 INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL?

The FDA product code for INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL is LJG.

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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: LJG)

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.

K943228MICROSPORIDIUM CONTROL SETMeridian Diagnostics, Inc.K924893MICROSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890670CRYPTOSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890718GRAM STAIN CONTROL SLIDEScientific Device Laboratory, Inc.K890616BION DIRECT IDENTIFICATION CONTROL SLIDEBion Ent., Ltd.K883569HISTO-CHECK GRAM NEGATIVE SLIDESVal Tech Diagnostics, 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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