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FDA 510(k)

FETAL HEMOGLOBIN

K-Number: K892241 · 1989-05-17

ApplicantSure-Tech Diagnostic Associates, Inc.
Decision Date1989-05-17
Product CodeGHQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FETAL HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Sure-Tech Diagnostic Associates, Inc.. It received FDA 510(k) clearance on 1989-05-17 under 510(k) number K892241. The device is classified under product code GHQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETAL HEMOGLOBIN?

FETAL HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1989-05-17. The listed applicant is Sure-Tech Diagnostic Associates, Inc.. The 510(k) number is K892241.

When did FETAL HEMOGLOBIN receive FDA 510(k) clearance?

FETAL HEMOGLOBIN received FDA 510(k) clearance on 1989-05-17, under 510(k) number K892241.

Who is the listed applicant for FETAL HEMOGLOBIN?

The FDA 510(k) record lists Sure-Tech Diagnostic Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FETAL HEMOGLOBIN?

The FDA product code for FETAL HEMOGLOBIN is GHQ.

Related Clinical Trials

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Related Devices (Code: GHQ)

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.

K990641CALTAG FETAL HEMOGLOBIN TESTCaltag Laboratories, Inc.

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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