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)

LSA 290 ASSAY REAGENTS/NEPHELOMETRIC

K-Number: K801909 · 1980-09-26

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-09-26
Product CodeDEX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LSA 290 ASSAY REAGENTS/NEPHELOMETRIC is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K801909. The device is classified under product code DEX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LSA 290 ASSAY REAGENTS/NEPHELOMETRIC?

LSA 290 ASSAY REAGENTS/NEPHELOMETRIC is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801909.

When did LSA 290 ASSAY REAGENTS/NEPHELOMETRIC receive FDA 510(k) clearance?

LSA 290 ASSAY REAGENTS/NEPHELOMETRIC received FDA 510(k) clearance on 1980-09-26, under 510(k) number K801909.

Who is the listed applicant for LSA 290 ASSAY REAGENTS/NEPHELOMETRIC?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LSA 290 ASSAY REAGENTS/NEPHELOMETRIC?

The FDA product code for LSA 290 ASSAY REAGENTS/NEPHELOMETRIC is DEX.

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 J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801662J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.

View all 54 devices →

Related Devices (Code: DEX)

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.

K823765ANTI SERA TO HUMAN OROSCOMUCOIDKent Laboratories, Inc.K791341HUMAN ALPHA, ACID GLYCOPROTEINBeckman Instruments, Inc.K781023ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HUIcl ScientificK760143SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMANOxford Laboratories, 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.

↑