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)

HEMATASTAT H-70

K-Number: K890849 · 1989-03-21

ApplicantSeparation Technology, Inc.
Decision Date1989-03-21
Product CodeGKG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATASTAT H-70 is the device name listed in this FDA 510(k) record. The listed applicant is Separation Technology, Inc.. It received FDA 510(k) clearance on 1989-03-21 under 510(k) number K890849. The device is classified under product code GKG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATASTAT H-70?

HEMATASTAT H-70 is a medical device that received FDA 510(k) clearance on 1989-03-21. The listed applicant is Separation Technology, Inc.. The 510(k) number is K890849.

When did HEMATASTAT H-70 receive FDA 510(k) clearance?

HEMATASTAT H-70 received FDA 510(k) clearance on 1989-03-21, under 510(k) number K890849.

Who is the listed applicant for HEMATASTAT H-70?

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

What is the FDA product code for HEMATASTAT H-70?

The FDA product code for HEMATASTAT H-70 is GKG.

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 Separation Technology, 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.

K913128HEMATASTAT C-70B

Related Devices (Code: GKG)

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.

K961803SPUNCRIT (MODEL DRC-40)Micro Diagnostics Corp.K955795MULTI-CENTRIFUGENovonx, Inc.K930415MICROHEMATOCRIT ROTORFisher Scientific Co., LLCK925863SPUNCRITbioMerieux, Inc.K920207HERMLE Z230HLabnet Intl., Inc.K920759CRITSPIN MICRO-HEMATOCRITStat-Spin Technologies

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.

↑