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FDA 510(k)

SERA-TEK MICROSOMAL ANTIBODY TEST

K-Number: K865053 · 1987-02-18

ApplicantMiles Laboratories, Inc.
Decision Date1987-02-18
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERA-TEK MICROSOMAL ANTIBODY 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 1987-02-18 under 510(k) number K865053. 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 SERA-TEK MICROSOMAL ANTIBODY TEST?

SERA-TEK MICROSOMAL ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1987-02-18. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K865053.

When did SERA-TEK MICROSOMAL ANTIBODY TEST receive FDA 510(k) clearance?

SERA-TEK MICROSOMAL ANTIBODY TEST received FDA 510(k) clearance on 1987-02-18, under 510(k) number K865053.

Who is the listed applicant for SERA-TEK MICROSOMAL ANTIBODY 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 SERA-TEK MICROSOMAL ANTIBODY TEST?

The FDA product code for SERA-TEK MICROSOMAL ANTIBODY TEST is 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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