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FDA 510(k)

QUANTIMETRIC PLUS SUPPORT PACK

K-Number: K855013 · 1986-02-26

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

Device Summary

QUANTIMETRIC PLUS SUPPORT PACK 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 K855013. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIMETRIC PLUS SUPPORT PACK?

QUANTIMETRIC PLUS SUPPORT PACK 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 K855013.

When did QUANTIMETRIC PLUS SUPPORT PACK receive FDA 510(k) clearance?

QUANTIMETRIC PLUS SUPPORT PACK received FDA 510(k) clearance on 1986-02-26, under 510(k) number K855013.

Who is the listed applicant for QUANTIMETRIC PLUS SUPPORT PACK?

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 SUPPORT PACK?

The FDA product code for QUANTIMETRIC PLUS SUPPORT PACK is DEH.

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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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