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)

H BROTH

K-Number: K823091 · 1982-11-05

ApplicantGranite Diagnostics, Inc.
Decision Date1982-11-05
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

H BROTH is the device name listed in this FDA 510(k) record. The listed applicant is Granite Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K823091. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H BROTH?

H BROTH is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Granite Diagnostics, Inc.. The 510(k) number is K823091.

When did H BROTH receive FDA 510(k) clearance?

H BROTH received FDA 510(k) clearance on 1982-11-05, under 510(k) number K823091.

Who is the listed applicant for H BROTH?

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

What is the FDA product code for H BROTH?

The FDA product code for H BROTH is JSH.

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 Granite 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.

K850969INHIBITORY MOLD AGAR PLATEK850970BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORAK833254STREPTOCOCCUS ID TRIPLATE SYSTEMK832365TCBS AGARK831349STREPTOCOCUS ID PLATEK830252DIPCHEX DIP-SLIDE CULTURE SYS

View all 47 devices →

Related Devices (Code: JSH)

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.

K881551PHENOL RED BROTH BASEAcumedia Manufacturers, Inc.K881553RUSSELL DOUBLE SUGAR AGARAcumedia Manufacturers, Inc.K881486DNASE TEST AGARAcumedia Manufacturers, Inc.K881540FLO AGARAcumedia Manufacturers, Inc.K881559UREA AGAR BASEAcumedia Manufacturers, Inc.K881560UREA BROTHAcumedia Manufacturers, 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.

↑