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FDA 510(k)

PORTABLE DIAGNOSTIC LABORATORY

K-Number: K844476 · 1985-03-13

ApplicantPortable Medical Laboratories, Inc.
Decision Date1985-03-13
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PORTABLE DIAGNOSTIC LABORATORY is the device name listed in this FDA 510(k) record. The listed applicant is Portable Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1985-03-13 under 510(k) number K844476. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE DIAGNOSTIC LABORATORY?

PORTABLE DIAGNOSTIC LABORATORY is a medical device that received FDA 510(k) clearance on 1985-03-13. The listed applicant is Portable Medical Laboratories, Inc.. The 510(k) number is K844476.

When did PORTABLE DIAGNOSTIC LABORATORY receive FDA 510(k) clearance?

PORTABLE DIAGNOSTIC LABORATORY received FDA 510(k) clearance on 1985-03-13, under 510(k) number K844476.

Who is the listed applicant for PORTABLE DIAGNOSTIC LABORATORY?

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

What is the FDA product code for PORTABLE DIAGNOSTIC LABORATORY?

The FDA product code for PORTABLE DIAGNOSTIC LABORATORY is LIB.

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 Portable Medical Laboratories, 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.

K882101HEMOGLOBIN SCREENING DEVICEK874190CELL COUNTING GRID GRATICULEK871671URINOSCOPY FUNNELK864049MCARTHUR MICROSCOPE, STANDARD METAL VERSIONK854735MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.K844475SPECIMEN COLLECTION & TRANSPORT SYSTEM

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Related Devices (Code: LIB)

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.

K023677OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)OsmetechK920416SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMBBehring Diagnostics, Inc.K912558GULL ELISAWAREGull Laboratories, Inc.K872273CORNING EASY WASH ELISA PLATESCorning Medical & ScientificK871559CELL LIFTERCorning Costar Corp.K864249NORMAL SALINE STERILEMds Laboratories, 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.

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