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FDA 510(k)

PROFILE CARDIAC SET ASSAYED SERUM CONTR.

K-Number: K803036 · 1980-12-22

ApplicantGeneral Diagnostics
Decision Date1980-12-22
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROFILE CARDIAC SET ASSAYED SERUM CONTR. is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803036. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILE CARDIAC SET ASSAYED SERUM CONTR.?

PROFILE CARDIAC SET ASSAYED SERUM CONTR. is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is General Diagnostics. The 510(k) number is K803036.

When did PROFILE CARDIAC SET ASSAYED SERUM CONTR. receive FDA 510(k) clearance?

PROFILE CARDIAC SET ASSAYED SERUM CONTR. received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803036.

Who is the listed applicant for PROFILE CARDIAC SET ASSAYED SERUM CONTR.?

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 PROFILE CARDIAC SET ASSAYED SERUM CONTR.?

The FDA product code for PROFILE CARDIAC SET ASSAYED SERUM CONTR. is DIF.

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Other records listing General Diagnostics as applicant

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K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, Inc.

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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