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FDA 510(k)

HEMOHLOBIN A2 CONTROL-LYOPHILIZED

K-Number: K801410 · 1980-07-21

ApplicantIsolab, Inc.
Decision Date1980-07-21
Product CodeJPD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOHLOBIN A2 CONTROL-LYOPHILIZED is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801410. The device is classified under product code JPD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOHLOBIN A2 CONTROL-LYOPHILIZED?

HEMOHLOBIN A2 CONTROL-LYOPHILIZED is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Isolab, Inc.. The 510(k) number is K801410.

When did HEMOHLOBIN A2 CONTROL-LYOPHILIZED receive FDA 510(k) clearance?

HEMOHLOBIN A2 CONTROL-LYOPHILIZED received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801410.

Who is the listed applicant for HEMOHLOBIN A2 CONTROL-LYOPHILIZED?

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 HEMOHLOBIN A2 CONTROL-LYOPHILIZED?

The FDA product code for HEMOHLOBIN A2 CONTROL-LYOPHILIZED is JPD.

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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: JPD)

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.

K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODETosoh Medics, Inc.K991127VARIANT II B-THALASSEMIABio-RadK924122VARIANT BETA-THALASSEMIA SHORT PROGRAMBio-RadK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITDrew Scientific , Ltd.K923318COLUMNMATE BETA-THAL HBA2 CONTROL - NORMALHelena LaboratoriesK923317COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMALHelena Laboratories

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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