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FDA 510(k)

HYPERFORMANCE CONTROLS (HP-CONTROLS)

K-Number: K871694 · 1987-07-07

ApplicantRapid Diagnostic Laboratories, Inc.
Decision Date1987-07-07
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

HYPERFORMANCE CONTROLS (HP-CONTROLS) is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Diagnostic Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-07 under 510(k) number K871694. 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 HYPERFORMANCE CONTROLS (HP-CONTROLS)?

HYPERFORMANCE CONTROLS (HP-CONTROLS) is a medical device that received FDA 510(k) clearance on 1987-07-07. The listed applicant is Rapid Diagnostic Laboratories, Inc.. The 510(k) number is K871694.

When did HYPERFORMANCE CONTROLS (HP-CONTROLS) receive FDA 510(k) clearance?

HYPERFORMANCE CONTROLS (HP-CONTROLS) received FDA 510(k) clearance on 1987-07-07, under 510(k) number K871694.

Who is the listed applicant for HYPERFORMANCE CONTROLS (HP-CONTROLS)?

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

What is the FDA product code for HYPERFORMANCE CONTROLS (HP-CONTROLS)?

The FDA product code for HYPERFORMANCE CONTROLS (HP-CONTROLS) is DIF.

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Other records listing Rapid Diagnostic Laboratories, 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.

K903909BLIND CONTROLS FOR DRUGS OF ABUSE TESTINGK890030NEW LOW LEVEL DRUG MIXTURE CONTROLK875216HIGH PERFORMANCE CALIBRATORSK863117HIGH PERFORMANCE CANNABINOID CONTROLSK850139COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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