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)

SERIES 810 PLATELET ANALYZER

K-Number: K803128 · 1981-04-03

ApplicantJ.T. Baker Chemical Co.
Decision Date1981-04-03
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SERIES 810 PLATELET ANALYZER 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 1981-04-03 under 510(k) number K803128. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 810 PLATELET ANALYZER?

SERIES 810 PLATELET ANALYZER is a medical device that received FDA 510(k) clearance on 1981-04-03. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K803128.

When did SERIES 810 PLATELET ANALYZER receive FDA 510(k) clearance?

SERIES 810 PLATELET ANALYZER received FDA 510(k) clearance on 1981-04-03, under 510(k) number K803128.

Who is the listed applicant for SERIES 810 PLATELET ANALYZER?

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 SERIES 810 PLATELET ANALYZER?

The FDA product code for SERIES 810 PLATELET ANALYZER is GKL.

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.

K802080BAKER DIAG. ULTRARATE CHLORIDE KITK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICK801662J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.

View all 54 devices →

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, 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.

↑