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FDA 510(k)

EASY-TEST HEMOGLOBIN (HGB) ITEM #16685

K-Number: K872653 · 1987-07-23

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-07-23
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-07-23 under 510(k) number K872653. 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 EASY-TEST HEMOGLOBIN (HGB) ITEM #16685?

EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 is a medical device that received FDA 510(k) clearance on 1987-07-23. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K872653.

When did EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 receive FDA 510(k) clearance?

EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 received FDA 510(k) clearance on 1987-07-23, under 510(k) number K872653.

Who is the listed applicant for EASY-TEST HEMOGLOBIN (HGB) ITEM #16685?

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

What is the FDA product code for EASY-TEST HEMOGLOBIN (HGB) ITEM #16685?

The FDA product code for EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 is KHG.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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.

K221508AnemoCheck HomeSanguina, Inc.K163215AnemoCheckSanguina, LLCK042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090Gds TechnologyK001462CARESIDE HEMOGLOBINCareside, Inc.K994073HEMOSITE TEST SYSTEMGds Technology, LLC

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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