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FDA 510(k)

AMMONIA ASSAY CAT. NO. 200-02

K-Number: K932556 · 1994-08-02

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1994-08-02
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA ASSAY CAT. NO. 200-02 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K932556. 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 ASSAY CAT. NO. 200-02?

AMMONIA ASSAY CAT. NO. 200-02 is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K932556.

When did AMMONIA ASSAY CAT. NO. 200-02 receive FDA 510(k) clearance?

AMMONIA ASSAY CAT. NO. 200-02 received FDA 510(k) clearance on 1994-08-02, under 510(k) number K932556.

Who is the listed applicant for AMMONIA ASSAY CAT. NO. 200-02?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMMONIA ASSAY CAT. NO. 200-02?

The FDA product code for AMMONIA ASSAY CAT. NO. 200-02 is JIF.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CALK912825MAGNESIUM ASSAY KIT, CAT.# 100-12

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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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