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)

PLATELET CONTROLS, NORMAL & ABNORMAL

K-Number: K760549 · 1976-10-08

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1976-10-08
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET CONTROLS, NORMAL & ABNORMAL is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1976-10-08 under 510(k) number K760549. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET CONTROLS, NORMAL & ABNORMAL?

PLATELET CONTROLS, NORMAL & ABNORMAL is a medical device that received FDA 510(k) clearance on 1976-10-08. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K760549.

When did PLATELET CONTROLS, NORMAL & ABNORMAL receive FDA 510(k) clearance?

PLATELET CONTROLS, NORMAL & ABNORMAL received FDA 510(k) clearance on 1976-10-08, under 510(k) number K760549.

Who is the listed applicant for PLATELET CONTROLS, NORMAL & ABNORMAL?

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

What is the FDA product code for PLATELET CONTROLS, NORMAL & ABNORMAL?

The FDA product code for PLATELET CONTROLS, NORMAL & ABNORMAL is JPK.

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 Dade, Baxter Travenol 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.

K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3K792606WHOLE BLOOD PLATELET CONTROL NORMAL,K792723BLOOD FLUID FILTERSK792607T3 UPTAKE (T3U) REAGENTSK792443TSH RADIOIMMUNOASSAYK792442FERRITIN RADIOIMMUNOASSAY

View all 44 devices →

Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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.

↑