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FDA 510(k)

SPECIMEN COLLECTION & TRANSPORT SYSTEM

K-Number: K844475 · 1985-02-06

ApplicantPortable Medical Laboratories, Inc.
Decision Date1985-02-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPECIMEN COLLECTION & TRANSPORT SYSTEM 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 1985-02-06 under 510(k) number K844475. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIMEN COLLECTION & TRANSPORT SYSTEM?

SPECIMEN COLLECTION & TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1985-02-06. The listed applicant is Portable Medical Laboratories, Inc.. The 510(k) number is K844475.

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

SPECIMEN COLLECTION & TRANSPORT SYSTEM received FDA 510(k) clearance on 1985-02-06, under 510(k) number K844475.

Who is the listed applicant for SPECIMEN COLLECTION & TRANSPORT SYSTEM?

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 SPECIMEN COLLECTION & TRANSPORT SYSTEM?

The FDA product code for SPECIMEN COLLECTION & TRANSPORT SYSTEM is FMF.

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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.

K882101HEMOGLOBIN SCREENING DEVICEK874190CELL COUNTING GRID GRATICULEK871671URINOSCOPY FUNNELK864049MCARTHUR MICROSCOPE, STANDARD METAL VERSIONK854735MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.K844476PORTABLE DIAGNOSTIC LABORATORY

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Related Devices (Code: FMF)

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.

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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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