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 STAIN KIT

K-Number: K781584 · 1978-10-10

ApplicantBioscientific
Decision Date1978-10-10
Product CodeHYI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GRAM STAIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioscientific. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781584. 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 STAIN KIT?

GRAM STAIN KIT is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Bioscientific. The 510(k) number is K781584.

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

GRAM STAIN KIT received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781584.

Who is the listed applicant for GRAM STAIN KIT?

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

What is the FDA product code for GRAM STAIN KIT?

The FDA product code for GRAM STAIN KIT 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 Bioscientific 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.

K812447AMYLASE REAGENT KITK811251CITRATE BUFFERK801268HEMOGLOBIN CONTROL LEVELSK801265WHITE BLOOD CELL COUNT CONTROL LEVELSK801267RED BLOOD CELL COUNT & HEMATOCRIT CNTLK791658WRIGHT STAIN PACK

View all 16 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.

K871286GRAM IODINERemel Co.K842733GRAM IODINEE K Ind., Inc.K821977GRAMSTAIN SETGranite Diagnostics, Inc.K811722PARA-PAKMeridian Diagnostics, Inc.K791711IMPROVED GRAM STAIN REAGENTSCarr-Scarborough Microbiologicals, 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.

↑