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, COCCI LATEX

K-Number: K782070 · 1979-02-01

ApplicantI M, Inc.
Decision Date1979-02-01
Product CodeGMG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REAGENT, COCCI LATEX is the device name listed in this FDA 510(k) record. The listed applicant is I M, Inc.. It received FDA 510(k) clearance on 1979-02-01 under 510(k) number K782070. The device is classified under product code GMG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT, COCCI LATEX?

REAGENT, COCCI LATEX is a medical device that received FDA 510(k) clearance on 1979-02-01. The listed applicant is I M, Inc.. The 510(k) number is K782070.

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

REAGENT, COCCI LATEX received FDA 510(k) clearance on 1979-02-01, under 510(k) number K782070.

Who is the listed applicant for REAGENT, COCCI LATEX?

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

What is the FDA product code for REAGENT, COCCI LATEX?

The FDA product code for REAGENT, COCCI LATEX is GMG.

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 I M, 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.

K914600NEUROLOGICAL SPONGEK892389BIOPSY KITK881363SYRINGE PREFILLED WITH WATERK880753UMBILICAL CORD CLAMPK872741NUTRIPUMPK871495BANDAGES CATALOG NUMBER: 101 TO 220

View all 41 devices →

Related Devices (Code: GMG)

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.

K812189COCCIDIOIDES LATEX AGGLUTINATIONAmerican Scientific ProductsK792690COCCIDIOIDES IMMITIS, LATEX AGGLUTIMeridian Diagnostics, Inc.K791381COCCIDIODES (COCCI)Immuno-Mycologics, Inc.K760829COCCIDIOIDES MYCELIAL ANTIGENI M, 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.

↑