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FDA 510(k)

AMMONIA REAGENT SET

K-Number: K915707 · 1992-02-26

ApplicantTech Intl. Co.
Decision Date1992-02-26
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech Intl. Co.. It received FDA 510(k) clearance on 1992-02-26 under 510(k) number K915707. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMONIA REAGENT SET?

AMMONIA REAGENT SET is a medical device that received FDA 510(k) clearance on 1992-02-26. The listed applicant is Tech Intl. Co.. The 510(k) number is K915707.

When did AMMONIA REAGENT SET receive FDA 510(k) clearance?

AMMONIA REAGENT SET received FDA 510(k) clearance on 1992-02-26, under 510(k) number K915707.

Who is the listed applicant for AMMONIA REAGENT SET?

The FDA 510(k) record lists Tech Intl. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMMONIA REAGENT SET?

The FDA product code for AMMONIA REAGENT SET is JIF.

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Other records listing Tech Intl. Co. 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.

K915704AMYLASE (KINETIC) REAGENT SETK915705ACID PHOSPHATASE REAGENT SETK914158URIC ACID REAGENT SETK915706LIPASE REAGENT SETK914160CHOLESTEROL REGEANT SETK915710AMYLASE (COLORIMETRIC) REAGENT SET

View all 13 devices →

Related Devices (Code: JIF)

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.

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. SrlK033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.

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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