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FDA 510(k)

QUANTIMETRIC 2 TEST KIT

K-Number: K813242 · 1981-12-02

ApplicantKallestad Laboratories, Inc.
Decision Date1981-12-02
Product CodeKEW
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIC 2 TEST 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 1981-12-02 under 510(k) number K813242. The device is classified under product code KEW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIC 2 TEST KIT?

QUANTIMETRIC 2 TEST KIT is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K813242.

When did QUANTIMETRIC 2 TEST KIT receive FDA 510(k) clearance?

QUANTIMETRIC 2 TEST KIT received FDA 510(k) clearance on 1981-12-02, under 510(k) number K813242.

Who is the listed applicant for QUANTIMETRIC 2 TEST 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 2 TEST KIT?

The FDA product code for QUANTIMETRIC 2 TEST KIT is KEW.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: KEW)

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.

K891604THE CEN-SLIDE(TM) CENTRIFUGE TUBEDavstar California, Inc.K890042MICROSCOPE SLIDES PRECOATEDStat PathK882357MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LYStat PathK831065SECTIONING AID KITTechnicon Instruments Corp.K820100FROSTED GLASS SLIDESStan-Pak Ent.K800232ABCO ULTRA SLIDE MICROSCOPE SLIDEAbco Dealers, 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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