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)

THERMOMETER KIT

K-Number: K780591 · 1978-04-19

ApplicantAbco Dealers, Inc.
Decision Date1978-04-19
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOMETER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1978-04-19 under 510(k) number K780591. The device is classified under product code FLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOMETER KIT?

THERMOMETER KIT is a medical device that received FDA 510(k) clearance on 1978-04-19. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K780591.

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

THERMOMETER KIT received FDA 510(k) clearance on 1978-04-19, under 510(k) number K780591.

Who is the listed applicant for THERMOMETER KIT?

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

What is the FDA product code for THERMOMETER KIT?

The FDA product code for THERMOMETER KIT is FLK.

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 Abco Dealers, 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.

K905025DIGITAL THERMOMETER KITSK882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)K880892BLOOD COLLECTING NEEDLE AND HOLDERSK880894ALLERGIST SYRINGESK872875STRETCH GAUZE BANDAGESK872874MICROSCOPE COVER GLASSES

View all 127 devices →

Related Devices (Code: FLK)

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.

K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.K953465KENTEMPKentron Health Care, Inc.K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.K941673MEDIAID UNIVERSAL THERMOMETERPolymedica Industries, Inc.K940394AMG MED BRAND CLINICAL GLASS THERMOMETERTechnolab Industries (Canada) , Ltd.

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.

↑