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FDA 510(k)

HEMOCARD HEMOGLOBIN S

K-Number: K911981 · 1991-10-09

ApplicantIsolab, Inc.
Decision Date1991-10-09
Product CodeGHM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCARD HEMOGLOBIN S is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1991-10-09 under 510(k) number K911981. The device is classified under product code GHM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCARD HEMOGLOBIN S?

HEMOCARD HEMOGLOBIN S is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Isolab, Inc.. The 510(k) number is K911981.

When did HEMOCARD HEMOGLOBIN S receive FDA 510(k) clearance?

HEMOCARD HEMOGLOBIN S received FDA 510(k) clearance on 1991-10-09, under 510(k) number K911981.

Who is the listed applicant for HEMOCARD HEMOGLOBIN S?

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

What is the FDA product code for HEMOCARD HEMOGLOBIN S?

The FDA product code for HEMOCARD HEMOGLOBIN S is GHM.

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Other records listing Isolab, 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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

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Related Devices (Code: GHM)

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.

K023656SICKLE-CHEX SOLUBILITY KITStreck Laboratories, Inc.K013316SICKLE-CHEXStreck Laboratories, Inc.K960947SAS SICKLE CELL TESTSa Scientific, Inc.K910430HEMOCARD-ASIsolab, Inc.K872217THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KITPacific HemostasisK860812SICKLE CELL REAGENT SETMichclone Associates, Inc.

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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