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FDA 510(k)

OPTIMATE IGA TEST

K-Number: K841815 · 1984-06-01

ApplicantMiles Laboratories, Inc.
Decision Date1984-06-01
Product CodeCZN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OPTIMATE IGA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1984-06-01 under 510(k) number K841815. The device is classified under product code CZN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMATE IGA TEST?

OPTIMATE IGA TEST is a medical device that received FDA 510(k) clearance on 1984-06-01. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K841815.

When did OPTIMATE IGA TEST receive FDA 510(k) clearance?

OPTIMATE IGA TEST received FDA 510(k) clearance on 1984-06-01, under 510(k) number K841815.

Who is the listed applicant for OPTIMATE IGA TEST?

The FDA 510(k) record lists Miles Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIMATE IGA TEST?

The FDA product code for OPTIMATE IGA TEST is CZN.

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Related Devices (Code: CZN)

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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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