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FDA 510(k)

IMMULISA INTRINSIC FACTOR ANTIBODY ELISA

K-Number: K071346 · 2007-09-24

ApplicantImmco Diagnostics, Inc.
Decision Date2007-09-24
Product CodeLIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULISA INTRINSIC FACTOR ANTIBODY ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2007-09-24 under 510(k) number K071346. The device is classified under product code LIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULISA INTRINSIC FACTOR ANTIBODY ELISA?

IMMULISA INTRINSIC FACTOR ANTIBODY ELISA is a medical device that received FDA 510(k) clearance on 2007-09-24. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K071346.

When did IMMULISA INTRINSIC FACTOR ANTIBODY ELISA receive FDA 510(k) clearance?

IMMULISA INTRINSIC FACTOR ANTIBODY ELISA received FDA 510(k) clearance on 2007-09-24, under 510(k) number K071346.

Who is the listed applicant for IMMULISA INTRINSIC FACTOR ANTIBODY ELISA?

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

What is the FDA product code for IMMULISA INTRINSIC FACTOR ANTIBODY ELISA?

The FDA product code for IMMULISA INTRINSIC FACTOR ANTIBODY ELISA is LIG.

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Other records listing Immco Diagnostics, Inc. as applicant

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Related Devices (Code: LIG)

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.

K240800Access Intrinsic Factor AbBeckman Coulter, Inc.K061841QUANTA LITE INTRINSIC FACTOR ELISAInova Diagnostics, Inc.K033603INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999Beckman Coulter, Inc.K993251IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6Diagnostic Products Corp.K984108ABBOTT ARCHITECT B12Abbott LaboratoriesK903218IMX B12Abbott 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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