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FDA 510(k)

GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED

K-Number: K861000 · 1986-04-03

ApplicantCiba Corning Diagnostics Corp.
Decision Date1986-04-03
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1986-04-03 under 510(k) number K861000. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED?

GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED is a medical device that received FDA 510(k) clearance on 1986-04-03. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K861000.

When did GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED receive FDA 510(k) clearance?

GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED received FDA 510(k) clearance on 1986-04-03, under 510(k) number K861000.

Who is the listed applicant for GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED?

The FDA 510(k) record lists Ciba Corning Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED?

The FDA product code for GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED is JJY.

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Other records listing Ciba Corning Diagnostics Corp. as applicant

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Related Devices (Code: JJY)

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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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