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)

SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE

K-Number: K884623 · 1988-12-01

ApplicantSafe-Tec Clinical Products, Inc.
Decision Date1988-12-01
Product CodeGIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Safe-Tec Clinical Products, Inc.. It received FDA 510(k) clearance on 1988-12-01 under 510(k) number K884623. The device is classified under product code GIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE?

SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE is a medical device that received FDA 510(k) clearance on 1988-12-01. The listed applicant is Safe-Tec Clinical Products, Inc.. The 510(k) number is K884623.

When did SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE receive FDA 510(k) clearance?

SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE received FDA 510(k) clearance on 1988-12-01, under 510(k) number K884623.

Who is the listed applicant for SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE?

The FDA 510(k) record lists Safe-Tec Clinical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE?

The FDA product code for SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE is GIO.

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 Safe-Tec Clinical Products, 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.

K890109SAFEPETTE DISPENSER

Related Devices (Code: GIO)

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.

K972969QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEMInnovative Medical Technologies, Inc.K941291MONOJECT SAMPLETTE SEPARATOR TUBESherwood Medical Co.K894851TRU-TRAXHumagen, Inc.K885324HEMA(PRO)TEC(TION)Medical Products Search, Inc.K885138CAPILLARY TUBE, BLOOD COLLECTIONCoeur Laboratories, Inc.K881262CARAWAY TUBES, HEPARIN AND PLAINHelps Products, 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.

↑