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FDA 510(k)

RAICHEM(TM) AMMONIA REAGENT

K-Number: K864706 · 1987-01-05

ApplicantReagents Applications, Inc.
Decision Date1987-01-05
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) AMMONIA REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1987-01-05 under 510(k) number K864706. 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 RAICHEM(TM) AMMONIA REAGENT?

RAICHEM(TM) AMMONIA REAGENT is a medical device that received FDA 510(k) clearance on 1987-01-05. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K864706.

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

RAICHEM(TM) AMMONIA REAGENT received FDA 510(k) clearance on 1987-01-05, under 510(k) number K864706.

Who is the listed applicant for RAICHEM(TM) AMMONIA REAGENT?

The FDA 510(k) record lists Reagents Applications, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAICHEM(TM) AMMONIA REAGENT?

The FDA product code for RAICHEM(TM) AMMONIA REAGENT is JIF.

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Other records listing Reagents Applications, Inc. 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.

K982056RAICHEM CO2 REAGENTK972853CHOLESTEROL RAPID LIQUID REAGENTK922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIK915191RAI-TROL ELEVATED LIPIDS CONTROLK913398RAICHEM(TM) CREATINE KINASE-MB REAGENTK911900RAICHEM SPIA C3 REAGENT

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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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