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FDA 510(k)

FAST FORMALERT

K-Number: K853555 · 1986-06-26

ApplicantOrganon Teknika Corp.
Decision Date1986-06-26
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FAST FORMALERT is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1986-06-26 under 510(k) number K853555. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAST FORMALERT?

FAST FORMALERT is a medical device that received FDA 510(k) clearance on 1986-06-26. The listed applicant is Organon Teknika Corp.. The 510(k) number is K853555.

When did FAST FORMALERT receive FDA 510(k) clearance?

FAST FORMALERT received FDA 510(k) clearance on 1986-06-26, under 510(k) number K853555.

Who is the listed applicant for FAST FORMALERT?

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

What is the FDA product code for FAST FORMALERT?

The FDA product code for FAST FORMALERT is KOC.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: KOC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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