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FDA 510(k)

AMMONIA TEST

K-Number: K813366 · 1981-12-22

ApplicantWako Pure Chemical Industries, Ltd.
Decision Date1981-12-22
Product CodeJID
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wako Pure Chemical Industries, Ltd.. It received FDA 510(k) clearance on 1981-12-22 under 510(k) number K813366. The device is classified under product code JID. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMONIA TEST?

AMMONIA TEST is a medical device that received FDA 510(k) clearance on 1981-12-22. The listed applicant is Wako Pure Chemical Industries, Ltd.. The 510(k) number is K813366.

When did AMMONIA TEST receive FDA 510(k) clearance?

AMMONIA TEST received FDA 510(k) clearance on 1981-12-22, under 510(k) number K813366.

Who is the listed applicant for AMMONIA TEST?

The FDA 510(k) record lists Wako Pure Chemical Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMMONIA TEST?

The FDA product code for AMMONIA TEST is JID.

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Other records listing Wako Pure Chemical Industries, Ltd. as applicant

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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Related Devices (Code: JID)

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.

K260613AMI™ Plasma Cartridge, AMI™Sequitur Health Corp.K991371CARESIDE AMMONIACareside, Inc.K820723KODAK EKTACHEM CLINICAL CHEM. NH3Eastman Kodak Company

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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