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FDA 510(k)

BENZODIAZEPINE ENZYME IMMUNOASSAY KIT

K-Number: K863877 · 1987-03-12

ApplicantGeneral Diagnostics
Decision Date1987-03-12
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BENZODIAZEPINE ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1987-03-12 under 510(k) number K863877. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENZODIAZEPINE ENZYME IMMUNOASSAY KIT?

BENZODIAZEPINE ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is General Diagnostics. The 510(k) number is K863877.

When did BENZODIAZEPINE ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

BENZODIAZEPINE ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1987-03-12, under 510(k) number K863877.

Who is the listed applicant for BENZODIAZEPINE ENZYME IMMUNOASSAY KIT?

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

What is the FDA product code for BENZODIAZEPINE ENZYME IMMUNOASSAY KIT?

The FDA product code for BENZODIAZEPINE ENZYME IMMUNOASSAY KIT is JXM.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK842307GENERAL DIAG. CEFONICID 30MCG ANTIMICK841465GENERAL DIAGNOSTICS PLATELET ANTIBODY

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Related Devices (Code: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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