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)

ENCORE CHEMISTRY ANALYZER

K-Number: K830641 · 1983-04-05

ApplicantBaker Instructions Corp.
Decision Date1983-04-05
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENCORE CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Baker Instructions Corp.. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830641. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCORE CHEMISTRY ANALYZER?

ENCORE CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Baker Instructions Corp.. The 510(k) number is K830641.

When did ENCORE CHEMISTRY ANALYZER receive FDA 510(k) clearance?

ENCORE CHEMISTRY ANALYZER received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830641.

Who is the listed applicant for ENCORE CHEMISTRY ANALYZER?

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

What is the FDA product code for ENCORE CHEMISTRY ANALYZER?

The FDA product code for ENCORE CHEMISTRY ANALYZER is JJG.

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 Baker Instructions Corp. 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.

K882612SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERK873596BAKER TDM THEOPHYLLINE ASSAYK870603SYSTEM 9000 AUTOMATED CELL COUNTERK854173UCD URINE SPECIMEN COLLECTORK850386SYSTEM 8000 CELL COUNTERK833116SPIRIT CHEMISTRY SYSTEM

View all 10 devices →

Related Devices (Code: JJG)

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.

K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.K942782PICCOLO(TM)Abaxis, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, 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.

↑