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FDA 510(k)

DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO

K-Number: K840404 · 1984-03-09

ApplicantTago, Inc.
Decision Date1984-03-09
Product CodeDAD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO is the device name listed in this FDA 510(k) record. The listed applicant is Tago, Inc.. It received FDA 510(k) clearance on 1984-03-09 under 510(k) number K840404. The device is classified under product code DAD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO?

DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO is a medical device that received FDA 510(k) clearance on 1984-03-09. The listed applicant is Tago, Inc.. The 510(k) number is K840404.

When did DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO receive FDA 510(k) clearance?

DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO received FDA 510(k) clearance on 1984-03-09, under 510(k) number K840404.

Who is the listed applicant for DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO?

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

What is the FDA product code for DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO?

The FDA product code for DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO is DAD.

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Other records listing Tago, 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.

K841734TAGO FIFFU-GEN, OROSOMUCOIDK841265TAGO DIFFU-GEN C-REACTIVE PROTEINK834218DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -K833129TAGO DIFFU-GEN-APOLIPOPROTEIN B-100K830611RA SCREENING TESTK830531MONO SCREENING TEST

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Related Devices (Code: DAD)

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.

K993480K-ASSAY HAPTOGLOBINKamiya Biomedical Co.K972639TINA-QUANT HAPTOGLOBINBoehringer Mannheim Corp.K964301N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.K963286IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENTBeckman Instruments, Inc.K952593N/T PROTEIN CONTROL SY/L, M AND HBehring Diagnostics, Inc.K915829IL TEST(TM) HAPTOGLOBIN (HPT)Instrumentation Laboratory CO

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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