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FDA 510(k)

LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL

K-Number: K911347 · 1991-06-10

ApplicantBio-Rad
Decision Date1991-06-10
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K911347. The device is classified under product code JCM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL?

LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Bio-Rad. The 510(k) number is K911347.

When did LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL receive FDA 510(k) clearance?

LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911347.

Who is the listed applicant for LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL?

The FDA product code for LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL is JCM.

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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Related Devices (Code: JCM)

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.

K053031EXTENDSURE HBFASC CONTROLCantebury Scientific , Ltd.K011389HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)Canterbury Health LaboratoriesK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINERoche Diagnostic Systems, Inc.K942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLSIsolab, Inc.K933086AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328Helena LaboratoriesK931234HEMOCARD CONTROL HB-AA, AE, FAA, FAEIsolab, 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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