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FDA 510(k)

HEMOGLOBIN SCREENING DEVICE

K-Number: K882101 · 1988-07-01

ApplicantPortable Medical Laboratories, Inc.
Decision Date1988-07-01
Product CodeKSL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN SCREENING DEVICE 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 1988-07-01 under 510(k) number K882101. The device is classified under product code KSL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN SCREENING DEVICE?

HEMOGLOBIN SCREENING DEVICE is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Portable Medical Laboratories, Inc.. The 510(k) number is K882101.

When did HEMOGLOBIN SCREENING DEVICE receive FDA 510(k) clearance?

HEMOGLOBIN SCREENING DEVICE received FDA 510(k) clearance on 1988-07-01, under 510(k) number K882101.

Who is the listed applicant for HEMOGLOBIN SCREENING DEVICE?

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 HEMOGLOBIN SCREENING DEVICE?

The FDA product code for HEMOGLOBIN SCREENING DEVICE is KSL.

Related Clinical Trials

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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.

K874190CELL COUNTING GRID GRATICULEK871671URINOSCOPY FUNNELK864049MCARTHUR MICROSCOPE, STANDARD METAL VERSIONK854735MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.K844476PORTABLE DIAGNOSTIC LABORATORYK844475SPECIMEN COLLECTION & TRANSPORT SYSTEM

View all 9 devices →

Related Devices (Code: KSL)

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.

K803095COPPER SULFATE SOLUTION SP. GR.1.055Accra 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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