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)

REAGENT, VDRL

K-Number: K760098 · 1976-08-03

ApplicantGamma Biologicals, Inc.
Decision Date1976-08-03
Product CodeGMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REAGENT, VDRL is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Biologicals, Inc.. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760098. The device is classified under product code GMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT, VDRL?

REAGENT, VDRL is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Gamma Biologicals, Inc.. The 510(k) number is K760098.

When did REAGENT, VDRL receive FDA 510(k) clearance?

REAGENT, VDRL received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760098.

Who is the listed applicant for REAGENT, VDRL?

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

What is the FDA product code for REAGENT, VDRL?

The FDA product code for REAGENT, VDRL is GMT.

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 Gamma Biologicals, 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.

K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONOK861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSISK832473GAMMA SLIDE TEST FOR PREGNANCYK820647GAMMA FETAL BLEED SCREENING TESTK813342GAMMA CHLOROQUINE DIPHOSPHATE SOLUTIONK820072FE-CULT PLUS

View all 21 devices →

Related Devices (Code: GMT)

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.

K971502SERODIA TP-PAScimedx Tekfile ServicesK911640OLYMPUS PK TP(TM) SYSTEM, MODIFICATIONOlympus Corp.K911266MODIFIED PK TP CONTROLOlympus Corp.K905038OLYMPUS PK-TP ABSORBENT KITFujirebio America, Inc.K896410CELLOGNOST SYPHILIS HBehring Diagnostics, Inc.K893124OLYMPUS PK(TM) TPFujirebio Diagnostics,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.

↑