FDA 510(k)

DIGICLOT 2-#820

K-Number: K812121 · 1981-11-16

Decision Date1981-11-16

Product CodeJPA

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

DIGICLOT 2-#820 is the device name listed in this FDA 510(k) record. The listed applicant is Volu Sol Medical Industries. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812121. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGICLOT 2-#820?

DIGICLOT 2-#820 is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Volu Sol Medical Industries. The 510(k) number is K812121.

When did DIGICLOT 2-#820 receive FDA 510(k) clearance?

DIGICLOT 2-#820 received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812121.

Who is the listed applicant for DIGICLOT 2-#820?

The FDA 510(k) record lists Volu Sol Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGICLOT 2-#820?

The FDA product code for DIGICLOT 2-#820 is JPA.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Volu Sol Medical Industries as applicant

K822128VOLU-SOL SINGLE DIFFERENTIAL STAIN K822126VOLU-SOL CARNOY FLUID K822129VOLU-SOL BOVINS FIXATIVE K822127VOLU-SOL ZENKERS FIXATIVE K822036VOLU-SOL DECALCIFER K822035VOLU-SOL GILLS EA

View all 66 devices →

Related Devices (Code: JPA)

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation K233790ACL TOP 970 CLInstrumentation Laboratory

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.