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FDA 510(k)

QUANTIMETRIC PLUS C3 REAGENT KIT

K-Number: K855011 · 1986-02-26

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

Device Summary

QUANTIMETRIC PLUS C3 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 K855011. The device is classified under product code CZN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIC PLUS C3 REAGENT KIT?

QUANTIMETRIC PLUS C3 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 K855011.

When did QUANTIMETRIC PLUS C3 REAGENT KIT receive FDA 510(k) clearance?

QUANTIMETRIC PLUS C3 REAGENT KIT received FDA 510(k) clearance on 1986-02-26, under 510(k) number K855011.

Who is the listed applicant for QUANTIMETRIC PLUS C3 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 C3 REAGENT KIT?

The FDA product code for QUANTIMETRIC PLUS C3 REAGENT KIT is CZN.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: CZN)

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.

K891683TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISERHelena LaboratoriesK841815OPTIMATE IGA TESTMiles Laboratories, Inc.K832262FITC GOAT ANTI-HUMAN IMMUNOGLOBULINSGelco Diagnostics, Inc.K832257GOAT ANTI-HUMAN IGA A CHAIN SPECIFICGelco Diagnostics, Inc.K831909RABBIT ANTISERUM TO HUMAN IGADako Corp.K831607FIAX IGA TEST KITIntl. Diagnostic Technology

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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