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FDA 510(k)

QUANTITOPE 125I-FOLATE RADIOASSAY KIT

K-Number: K780508 · 1978-05-03

ApplicantKallestad Laboratories, Inc.
Decision Date1978-05-03
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTITOPE 125I-FOLATE RADIOASSAY 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 1978-05-03 under 510(k) number K780508. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTITOPE 125I-FOLATE RADIOASSAY KIT?

QUANTITOPE 125I-FOLATE RADIOASSAY KIT is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K780508.

When did QUANTITOPE 125I-FOLATE RADIOASSAY KIT receive FDA 510(k) clearance?

QUANTITOPE 125I-FOLATE RADIOASSAY KIT received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780508.

Who is the listed applicant for QUANTITOPE 125I-FOLATE RADIOASSAY 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 QUANTITOPE 125I-FOLATE RADIOASSAY KIT?

The FDA product code for QUANTITOPE 125I-FOLATE RADIOASSAY KIT is CGN.

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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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