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FDA 510(k)

ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET

K-Number: K890674 · 1989-02-24

ApplicantSigma Diagnostics, Inc.
Decision Date1989-02-24
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET 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 1989-02-24 under 510(k) number K890674. The device is classified under product code IAF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET?

ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET is a medical device that received FDA 510(k) clearance on 1989-02-24. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K890674.

When did ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET receive FDA 510(k) clearance?

ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET received FDA 510(k) clearance on 1989-02-24, under 510(k) number K890674.

Who is the listed applicant for ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET?

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 ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET?

The FDA product code for ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET is IAF.

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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: IAF)

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.

K890673WRIGHT-GLEMSA STAINSigma Diagnostics, Inc.K854236HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDSNms Pharmaceuticals, Inc.K860793CAMCO STAIN PAKCambridge Chemical Products, Inc.K853241HEMATOLOGY STAIN PACKFisher Scientific Co., LLCK852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon Diagnostics, Inc.K842744WRIGHT STAINE K Ind., 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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