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FDA 510(k)

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET

K-Number: K913427 · 1991-11-19

ApplicantCreative Laboratory Products, Inc.
Decision Date1991-11-19
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Creative Laboratory Products, Inc.. It received FDA 510(k) clearance on 1991-11-19 under 510(k) number K913427. 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 SICKLE HEMOGLOBIN (HBA/S) CONTROL SET?

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Creative Laboratory Products, Inc.. The 510(k) number is K913427.

When did SICKLE HEMOGLOBIN (HBA/S) CONTROL SET receive FDA 510(k) clearance?

SICKLE HEMOGLOBIN (HBA/S) CONTROL SET received FDA 510(k) clearance on 1991-11-19, under 510(k) number K913427.

Who is the listed applicant for SICKLE HEMOGLOBIN (HBA/S) CONTROL SET?

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

What is the FDA product code for SICKLE HEMOGLOBIN (HBA/S) CONTROL SET?

The FDA product code for SICKLE HEMOGLOBIN (HBA/S) CONTROL SET is JCM.

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Other records listing Creative Laboratory Products, 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.

K950589CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HLK942284CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SETK922995LIPID CONTROLSK913371TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CALK913585LIPASE LINEARITY CONTROLK913224LIPID LINEARITY CONTROLS

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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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