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FDA 510(k)

TEST, AMMONIA, BMC REAGENTSET

K-Number: K770273 · 1977-03-01

ApplicantBoehringer Mannheim Corp.
Decision Date1977-03-01
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TEST, AMMONIA, BMC REAGENTSET is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K770273. 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 TEST, AMMONIA, BMC REAGENTSET?

TEST, AMMONIA, BMC REAGENTSET is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K770273.

When did TEST, AMMONIA, BMC REAGENTSET receive FDA 510(k) clearance?

TEST, AMMONIA, BMC REAGENTSET received FDA 510(k) clearance on 1977-03-01, under 510(k) number K770273.

Who is the listed applicant for TEST, AMMONIA, BMC REAGENTSET?

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

What is the FDA product code for TEST, AMMONIA, BMC REAGENTSET?

The FDA product code for TEST, AMMONIA, BMC REAGENTSET 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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