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)

CHLORIDE

K-Number: K771832 · 1977-11-22

ApplicantGamma Enterprises, Inc.
Decision Date1977-11-22
Product CodeJFS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHLORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Enterprises, Inc.. It received FDA 510(k) clearance on 1977-11-22 under 510(k) number K771832. The device is classified under product code JFS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLORIDE?

CHLORIDE is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Gamma Enterprises, Inc.. The 510(k) number is K771832.

When did CHLORIDE receive FDA 510(k) clearance?

CHLORIDE received FDA 510(k) clearance on 1977-11-22, under 510(k) number K771832.

Who is the listed applicant for CHLORIDE?

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

What is the FDA product code for CHLORIDE?

The FDA product code for CHLORIDE is JFS.

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 Enterprises, 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.

K790578GAMMA SMAC REAGENTSK780506CARBON DIOXIDE REAGENTSK780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEK780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASEK780504CREATINE PHOSPHOKINASE (CPK)K771843WETTING AGENTS

View all 23 devices →

Related Devices (Code: JFS)

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.

K121823CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICWescor, Inc.K923598REDI-CHECK PHOTMETER Q.A.Awareness Technology, Inc.K873127CHLORIDE REAGENT KITA-Kem, Inc.K830217REAGENTS CORNING CHLORIDE METER FORFisher Scientific Co., LLCK823106RERMCO TEST CHLORIDE REAGENTFermco Biochemics, Inc.K820411LIQUIZYME CHLORIDE REAGENTAmerican Research Products Co.

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.

↑