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FDA 510(k)

ALLERCOAT POSITIVE CONTROL SERUM

K-Number: K823403 · 1982-12-15

ApplicantKallestad Laboratories, Inc.
Decision Date1982-12-15
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALLERCOAT POSITIVE CONTROL SERUM 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 1982-12-15 under 510(k) number K823403. 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 ALLERCOAT POSITIVE CONTROL SERUM?

ALLERCOAT POSITIVE CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K823403.

When did ALLERCOAT POSITIVE CONTROL SERUM receive FDA 510(k) clearance?

ALLERCOAT POSITIVE CONTROL SERUM received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823403.

Who is the listed applicant for ALLERCOAT POSITIVE CONTROL SERUM?

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 ALLERCOAT POSITIVE CONTROL SERUM?

The FDA product code for ALLERCOAT POSITIVE CONTROL SERUM is DGC.

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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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