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FDA 510(k)

U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)

K-Number: K862641 · 1986-08-21

ApplicantU. S. Diagnostics, Inc.
Decision Date1986-08-21
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-08-21 under 510(k) number K862641. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)?

U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) is a medical device that received FDA 510(k) clearance on 1986-08-21. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K862641.

When did U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) receive FDA 510(k) clearance?

U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) received FDA 510(k) clearance on 1986-08-21, under 510(k) number K862641.

Who is the listed applicant for U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)?

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

What is the FDA product code for U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)?

The FDA product code for U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) is KHG.

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Other records listing U. S. Diagnostics, Inc. as applicant

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K110435EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEMK082201G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024AK061431EASYGLUCO, MODEL IGM-0002 G2K051651G4, MODEL IGM-0004K870596PROTHROMBIN TIME TESTK870687COAGULATION CONTROL, LEVEL III

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Related Devices (Code: KHG)

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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