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FDA 510(k)

KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT

K-Number: K854483 · 1985-12-11

ApplicantKallestad Laboratories, Inc.
Decision Date1985-12-11
Product CodeKTO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD QUANTIMETRIC PLUS IGG 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 1985-12-11 under 510(k) number K854483. The device is classified under product code KTO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT?

KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT is a medical device that received FDA 510(k) clearance on 1985-12-11. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K854483.

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

KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT received FDA 510(k) clearance on 1985-12-11, under 510(k) number K854483.

Who is the listed applicant for KALLESTAD QUANTIMETRIC PLUS IGG 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 KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT?

The FDA product code for KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT is KTO.

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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: KTO)

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.

K894416RAICHEM(TM) SPIA(TM) IGG REAGENTSReagents Applications, 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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