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)

CUSTOMED BLOOD EXTRACTION KIT

K-Number: K962596 · 1996-09-27

ApplicantCustomed, Inc.
Decision Date1996-09-27
Product CodeGJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CUSTOMED BLOOD EXTRACTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1996-09-27 under 510(k) number K962596. The device is classified under product code GJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOMED BLOOD EXTRACTION KIT?

CUSTOMED BLOOD EXTRACTION KIT is a medical device that received FDA 510(k) clearance on 1996-09-27. The listed applicant is Customed, Inc.. The 510(k) number is K962596.

When did CUSTOMED BLOOD EXTRACTION KIT receive FDA 510(k) clearance?

CUSTOMED BLOOD EXTRACTION KIT received FDA 510(k) clearance on 1996-09-27, under 510(k) number K962596.

Who is the listed applicant for CUSTOMED BLOOD EXTRACTION KIT?

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

What is the FDA product code for CUSTOMED BLOOD EXTRACTION KIT?

The FDA product code for CUSTOMED BLOOD EXTRACTION KIT is GJE.

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 Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K961442UNIVERSAL DRAINAGE TRAYK953678STERIMED STERIZATION WRAPPER (NON-STERILE)

View all 36 devices →

Related Devices (Code: GJE)

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.

K925468JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KITJ.J. Skinner, Inc.K780303AUTO ISO-FILTER COLLECTION TUBE CAPBd Becton Dickinson Vacutainer Systems PreanalyticK771489RTERIAL BLOOD SAMPLING KITBd Becton Dickinson Vacutainer Systems PreanalyticK771370ICROTAINEO BRAND TUBEBd Becton Dickinson Vacutainer Systems PreanalyticK761177SODIUM CITRATEBio/Data Corp.K760086TRAY, BLOOD SAMPLING (PULSATOR II)Concord 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.

↑