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FDA 510(k)

SAMM

K-Number: K820828 · 1982-04-14

ApplicantDart Medical Equipment
Decision Date1982-04-14
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAMM is the device name listed in this FDA 510(k) record. The listed applicant is Dart Medical Equipment. It received FDA 510(k) clearance on 1982-04-14 under 510(k) number K820828. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAMM?

SAMM is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is Dart Medical Equipment. The 510(k) number is K820828.

When did SAMM receive FDA 510(k) clearance?

SAMM received FDA 510(k) clearance on 1982-04-14, under 510(k) number K820828.

Who is the listed applicant for SAMM?

The FDA 510(k) record lists Dart Medical Equipment as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAMM?

The FDA product code for SAMM is DXH. This falls under the Hematology category.

Other records listing Dart Medical Equipment 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.

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Related Devices (Code: DXH)

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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