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FDA 510(k)

APOLIPOPROTIEN B (APO B)

K-Number: K932603 · 1994-06-02

ApplicantSigma Diagnostics, Inc.
Decision Date1994-06-02
Product CodeJHN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APOLIPOPROTIEN B (APO B) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K932603. The device is classified under product code JHN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APOLIPOPROTIEN B (APO B)?

APOLIPOPROTIEN B (APO B) is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K932603.

When did APOLIPOPROTIEN B (APO B) receive FDA 510(k) clearance?

APOLIPOPROTIEN B (APO B) received FDA 510(k) clearance on 1994-06-02, under 510(k) number K932603.

Who is the listed applicant for APOLIPOPROTIEN B (APO B)?

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

What is the FDA product code for APOLIPOPROTIEN B (APO B)?

The FDA product code for APOLIPOPROTIEN B (APO B) is JHN.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

View all 164 devices →

Related Devices (Code: JHN)

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.

K950383APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KITRandox Laboratories, Ltd.K950382APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KITRandox Laboratories, Ltd.K952615WAKO AUTOKIT APO A1Wako Chemicals USA, Inc.K952425OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K952466OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K932606APOLIPOPROTIEN A-1 (APO A-1)Sigma Diagnostics, 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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