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FDA 510(k)

RETICULOCYTE STAIN

K-Number: K875310 · 1988-02-09

ApplicantSigma Diagnostics, Inc.
Decision Date1988-02-09
Product CodeKFC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RETICULOCYTE STAIN 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 1988-02-09 under 510(k) number K875310. The device is classified under product code KFC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETICULOCYTE STAIN?

RETICULOCYTE STAIN is a medical device that received FDA 510(k) clearance on 1988-02-09. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K875310.

When did RETICULOCYTE STAIN receive FDA 510(k) clearance?

RETICULOCYTE STAIN received FDA 510(k) clearance on 1988-02-09, under 510(k) number K875310.

Who is the listed applicant for RETICULOCYTE STAIN?

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 RETICULOCYTE STAIN?

The FDA product code for RETICULOCYTE STAIN is KFC.

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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: KFC)

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.

K843919SPOTTEST LOEFFLER METHYLENE BLUE STAINDifco Laboratories, Inc.K842785STAIN, METHYLENE BLUE-EOSINReagent Laboratory, Inc.K842926METHYLENE BLUE STAIN, LOEFFLERE K Ind., Inc.K842743NEW METHYLENE BLUE NE K Ind., Inc.K831502NEPHROLYTEFlaitron Laboratories, Inc.K770792TUBE, STAIN, RETICULOCYTE, LARCCorning Medical & Scientific

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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