Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TISSUE GRAM STAIN

K-Number: K864531 · 1986-12-22

ApplicantSigma Diagnostics, Inc.
Decision Date1986-12-22
Product CodeICF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TISSUE GRAM 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 1986-12-22 under 510(k) number K864531. The device is classified under product code ICF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE GRAM STAIN?

TISSUE GRAM STAIN is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K864531.

When did TISSUE GRAM STAIN receive FDA 510(k) clearance?

TISSUE GRAM STAIN received FDA 510(k) clearance on 1986-12-22, under 510(k) number K864531.

Who is the listed applicant for TISSUE GRAM 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 TISSUE GRAM STAIN?

The FDA product code for TISSUE GRAM STAIN is ICF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: ICF)

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.

K842537VON WILLEBRAND FACTOR ANTIGEN SCREENAmerican DadeK842730GENTIAN VIOLETE K Ind., Inc.K821503IRIS URINE STAINIntl. Remote Imaging SystemsK792495VOLU-SOL URINARY SEDIMENT STAINVolu Sol Medical Industries

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.

↑