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FDA 510(k)

PARAMAX AMMONIA AND AMMONIA BLANK REAGENT

K-Number: K964565 · 1996-11-22

ApplicantDade Intl., Inc.
Decision Date1996-11-22
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX AMMONIA AND AMMONIA BLANK REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Dade Intl., Inc.. It received FDA 510(k) clearance on 1996-11-22 under 510(k) number K964565. 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 PARAMAX AMMONIA AND AMMONIA BLANK REAGENT?

PARAMAX AMMONIA AND AMMONIA BLANK REAGENT is a medical device that received FDA 510(k) clearance on 1996-11-22. The listed applicant is Dade Intl., Inc.. The 510(k) number is K964565.

When did PARAMAX AMMONIA AND AMMONIA BLANK REAGENT receive FDA 510(k) clearance?

PARAMAX AMMONIA AND AMMONIA BLANK REAGENT received FDA 510(k) clearance on 1996-11-22, under 510(k) number K964565.

Who is the listed applicant for PARAMAX AMMONIA AND AMMONIA BLANK REAGENT?

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

What is the FDA product code for PARAMAX AMMONIA AND AMMONIA BLANK REAGENT?

The FDA product code for PARAMAX AMMONIA AND AMMONIA BLANK REAGENT is JIF.

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Other records listing Dade Intl., 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.

K974343DADE INNOVINK970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/K973974DADE TRU-LIQUID CARDIAC CONTROLK973668CARDIAC TROPONIN-I (TROP) CALIBRATORK972524DRIED GRAM-POSITIVE MIC/COMBO PANELSK972782DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

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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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