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)

SAMPLING KIT

K-Number: K801146 · 1980-06-04

ApplicantPharmaseal Laboratories
Decision Date1980-06-04
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SAMPLING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Laboratories. It received FDA 510(k) clearance on 1980-06-04 under 510(k) number K801146. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMPLING KIT?

SAMPLING KIT is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Pharmaseal Laboratories. The 510(k) number is K801146.

When did SAMPLING KIT receive FDA 510(k) clearance?

SAMPLING KIT received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801146.

Who is the listed applicant for SAMPLING KIT?

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

What is the FDA product code for SAMPLING KIT?

The FDA product code for SAMPLING KIT is CBT.

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 Pharmaseal Laboratories 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.

K800737DEBRISAN (DEXTRANOMER) PASTEK800874PELVIC EXAM TRAYK800362FLUID DISPENSING SYSTEMK760469CLEANSING AGENT, NEW WOUND (DEBRISSU)

Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K954035ACTI-FLEX ARTERIAL EXTENSION SETR-Group Intl.K950098NEEDLE SAFETY COVERHammer-Plane, 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.

↑