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FDA 510(k)

HAPTOGLOBIN NEPHELOMETRIC ASSAY

K-Number: K801433 · 1980-07-08

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-07-08
Product CodeDAD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HAPTOGLOBIN NEPHELOMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801433. 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 HAPTOGLOBIN NEPHELOMETRIC ASSAY?

HAPTOGLOBIN NEPHELOMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801433.

When did HAPTOGLOBIN NEPHELOMETRIC ASSAY receive FDA 510(k) clearance?

HAPTOGLOBIN NEPHELOMETRIC ASSAY received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801433.

Who is the listed applicant for HAPTOGLOBIN NEPHELOMETRIC ASSAY?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAPTOGLOBIN NEPHELOMETRIC ASSAY?

The FDA product code for HAPTOGLOBIN NEPHELOMETRIC ASSAY is DAD.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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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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