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FDA 510(k)

LUDLUM 88 DOSE CALIBRATOR

K-Number: K842570 · 1984-08-07

ApplicantLudlum Measurements, Inc.
Decision Date1984-08-07
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUDLUM 88 DOSE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ludlum Measurements, Inc.. It received FDA 510(k) clearance on 1984-08-07 under 510(k) number K842570. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUDLUM 88 DOSE CALIBRATOR?

LUDLUM 88 DOSE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1984-08-07. The listed applicant is Ludlum Measurements, Inc.. The 510(k) number is K842570.

When did LUDLUM 88 DOSE CALIBRATOR receive FDA 510(k) clearance?

LUDLUM 88 DOSE CALIBRATOR received FDA 510(k) clearance on 1984-08-07, under 510(k) number K842570.

Who is the listed applicant for LUDLUM 88 DOSE CALIBRATOR?

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

What is the FDA product code for LUDLUM 88 DOSE CALIBRATOR?

The FDA product code for LUDLUM 88 DOSE CALIBRATOR is KPT. This falls under the In Vitro Diagnostics category.

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Related Devices (Code: KPT)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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