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FDA 510(k)

QUANTAFLUOR FLUORESCENT TEST REAGENTS

K-Number: K813592 · 1982-01-18

ApplicantKallestad Laboratories, Inc.
Decision Date1982-01-18
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTAFLUOR FLUORESCENT TEST REAGENTS 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 1982-01-18 under 510(k) number K813592. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTAFLUOR FLUORESCENT TEST REAGENTS?

QUANTAFLUOR FLUORESCENT TEST REAGENTS is a medical device that received FDA 510(k) clearance on 1982-01-18. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K813592.

When did QUANTAFLUOR FLUORESCENT TEST REAGENTS receive FDA 510(k) clearance?

QUANTAFLUOR FLUORESCENT TEST REAGENTS received FDA 510(k) clearance on 1982-01-18, under 510(k) number K813592.

Who is the listed applicant for QUANTAFLUOR FLUORESCENT TEST REAGENTS?

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 QUANTAFLUOR FLUORESCENT TEST REAGENTS?

The FDA product code for QUANTAFLUOR FLUORESCENT TEST REAGENTS is DHN.

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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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