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FDA 510(k)

KALLESTAD QUANTITOPE LOW LEVEL IGE REAG

K-Number: K811545 · 1981-06-24

ApplicantKallestad Laboratories, Inc.
Decision Date1981-06-24
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD QUANTITOPE LOW LEVEL IGE REAG 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 1981-06-24 under 510(k) number K811545. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALLESTAD QUANTITOPE LOW LEVEL IGE REAG?

KALLESTAD QUANTITOPE LOW LEVEL IGE REAG is a medical device that received FDA 510(k) clearance on 1981-06-24. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K811545.

When did KALLESTAD QUANTITOPE LOW LEVEL IGE REAG receive FDA 510(k) clearance?

KALLESTAD QUANTITOPE LOW LEVEL IGE REAG received FDA 510(k) clearance on 1981-06-24, under 510(k) number K811545.

Who is the listed applicant for KALLESTAD QUANTITOPE LOW LEVEL IGE REAG?

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 KALLESTAD QUANTITOPE LOW LEVEL IGE REAG?

The FDA product code for KALLESTAD QUANTITOPE LOW LEVEL IGE REAG is DGC.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: DGC)

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.

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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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