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FDA 510(k)

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST

K-Number: K881933 · 1988-06-06

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-06-06
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1988-06-06 under 510(k) number K881933. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST?

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1988-06-06. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K881933.

When did KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST receive FDA 510(k) clearance?

KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST received FDA 510(k) clearance on 1988-06-06, under 510(k) number K881933.

Who is the listed applicant for KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST?

The FDA product code for KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST is JZO.

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Related Devices (Code: JZO)

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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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