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FDA 510(k)

QUANTIMETRIC PLUS IGA REAGENT KIT

K-Number: K855009 · 1986-02-26

ApplicantKallestad Laboratories, Inc.
Decision Date1986-02-26
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIC PLUS IGA REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1986-02-26 under 510(k) number K855009. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIC PLUS IGA REAGENT KIT?

QUANTIMETRIC PLUS IGA REAGENT KIT is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K855009.

When did QUANTIMETRIC PLUS IGA REAGENT KIT receive FDA 510(k) clearance?

QUANTIMETRIC PLUS IGA REAGENT KIT received FDA 510(k) clearance on 1986-02-26, under 510(k) number K855009.

Who is the listed applicant for QUANTIMETRIC PLUS IGA REAGENT KIT?

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

What is the FDA product code for QUANTIMETRIC PLUS IGA REAGENT KIT?

The FDA product code for QUANTIMETRIC PLUS IGA REAGENT KIT is CZP.

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Other records listing Kallestad Laboratories, 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott 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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