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)

GRAM IODINE

K-Number: K871286 · 1987-04-08

ApplicantRemel Co.
Decision Date1987-04-08
Product CodeHYI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GRAM IODINE is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1987-04-08 under 510(k) number K871286. The device is classified under product code HYI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM IODINE?

GRAM IODINE is a medical device that received FDA 510(k) clearance on 1987-04-08. The listed applicant is Remel Co.. The 510(k) number is K871286.

When did GRAM IODINE receive FDA 510(k) clearance?

GRAM IODINE received FDA 510(k) clearance on 1987-04-08, under 510(k) number K871286.

Who is the listed applicant for GRAM IODINE?

The FDA 510(k) record lists Remel Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAM IODINE?

The FDA product code for GRAM IODINE is HYI.

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 Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

View all 137 devices →

Related Devices (Code: HYI)

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.

K842733GRAM IODINEE K Ind., Inc.K821977GRAMSTAIN SETGranite Diagnostics, Inc.K811722PARA-PAKMeridian Diagnostics, Inc.K791711IMPROVED GRAM STAIN REAGENTSCarr-Scarborough Microbiologicals, Inc.K781584GRAM STAIN KITBioscientific

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.

↑