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)

PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM

K-Number: K884357 · 1988-11-01

ApplicantPrecision Dynamics Corp.
Decision Date1988-11-01
Product CodeKOT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dynamics Corp.. It received FDA 510(k) clearance on 1988-11-01 under 510(k) number K884357. The device is classified under product code KOT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM?

PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1988-11-01. The listed applicant is Precision Dynamics Corp.. The 510(k) number is K884357.

When did PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM receive FDA 510(k) clearance?

PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM received FDA 510(k) clearance on 1988-11-01, under 510(k) number K884357.

Who is the listed applicant for PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM?

The FDA 510(k) record lists Precision Dynamics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM?

The FDA product code for PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM is KOT.

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 Precision Dynamics Corp. 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.

K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEK994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565K994263SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540K990737'ECURLINE UMBILICAL CORD CLAMP #3500K882580MECHANICAL CHANGE IN IN-VITRO MICRO DEVICEK874665SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY

View all 25 devices →

Related Devices (Code: KOT)

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.

K945462SUPER POLI-GRIP DENTURE ADHESIVE CREAMBlock Drug Company, Inc.K941365MPI DENTURE ADHESIVE FILM SEALSMedical Polymers, Inc.K903568SUPER STRENGTH DENTURE ADHESIVE CREAMTeledyne GetzK895818STEADFAST DENTURE ADHESIVE CREAMStiefel Research Institute, Inc.K872225SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDERBlock Drug Company, Inc.K854430RIGIDENT CREAMArmkel, LLC

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.

↑