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)

STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW

K-Number: K060968 · 2007-05-15

ApplicantWortham Laboratories, Inc.
Decision Date2007-05-15
Product CodeGIZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW is the device name listed in this FDA 510(k) record. The listed applicant is Wortham Laboratories, Inc.. It received FDA 510(k) clearance on 2007-05-15 under 510(k) number K060968. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW?

STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW is a medical device that received FDA 510(k) clearance on 2007-05-15. The listed applicant is Wortham Laboratories, Inc.. The 510(k) number is K060968.

When did STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW receive FDA 510(k) clearance?

STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW received FDA 510(k) clearance on 2007-05-15, under 510(k) number K060968.

Who is the listed applicant for STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW?

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

What is the FDA product code for STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW?

The FDA product code for STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW is GIZ.

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

Related Devices (Code: GIZ)

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.

K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade Behring, Inc.K984129COAGULATION CONTROL LEVEL 1 (NORMAL)Pacific Hemostasis

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.

↑