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FDA 510(k)

MODEL SCR-1000

K-Number: K913400 · 1991-08-21

ApplicantAccucore, Inc.
Decision Date1991-08-21
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL SCR-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Accucore, Inc.. It received FDA 510(k) clearance on 1991-08-21 under 510(k) number K913400. 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 MODEL SCR-1000?

MODEL SCR-1000 is a medical device that received FDA 510(k) clearance on 1991-08-21. The listed applicant is Accucore, Inc.. The 510(k) number is K913400.

When did MODEL SCR-1000 receive FDA 510(k) clearance?

MODEL SCR-1000 received FDA 510(k) clearance on 1991-08-21, under 510(k) number K913400.

Who is the listed applicant for MODEL SCR-1000?

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

What is the FDA product code for MODEL SCR-1000?

The FDA product code for MODEL SCR-1000 is DXH. This falls under the Hematology category.

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Other records listing Accucore, Inc. as applicant

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Related Devices (Code: DXH)

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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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