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FDA 510(k)

ABBOTT SPECTRUM AMMONIA REAGENT

K-Number: K870787 · 1987-03-31

ApplicantAbbott Laboratories
Decision Date1987-03-31
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT SPECTRUM AMMONIA REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-03-31 under 510(k) number K870787. 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 ABBOTT SPECTRUM AMMONIA REAGENT?

ABBOTT SPECTRUM AMMONIA REAGENT is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is Abbott Laboratories. The 510(k) number is K870787.

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

ABBOTT SPECTRUM AMMONIA REAGENT received FDA 510(k) clearance on 1987-03-31, under 510(k) number K870787.

Who is the listed applicant for ABBOTT SPECTRUM AMMONIA REAGENT?

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

What is the FDA product code for ABBOTT SPECTRUM AMMONIA REAGENT?

The FDA product code for ABBOTT SPECTRUM AMMONIA REAGENT is JIF.

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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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