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FDA 510(k)

HEMOGLOBIN

K-Number: K883683 · 1988-10-06

ApplicantTech-Co, Inc.
Decision Date1988-10-06
Product CodeGJZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K883683. The device is classified under product code GJZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN?

HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Tech-Co, Inc.. The 510(k) number is K883683.

When did HEMOGLOBIN receive FDA 510(k) clearance?

HEMOGLOBIN received FDA 510(k) clearance on 1988-10-06, under 510(k) number K883683.

Who is the listed applicant for HEMOGLOBIN?

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

What is the FDA product code for HEMOGLOBIN?

The FDA product code for HEMOGLOBIN is GJZ.

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Other records listing Tech-Co, Inc. 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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Related Devices (Code: GJZ)

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.

K881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINAbbott Diagnostics

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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