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FDA 510(k)

HIGH PERFORMANCE CALIBRATORS

K-Number: K875216 · 1988-06-22

ApplicantRapid Diagnostic Laboratories, Inc.
Decision Date1988-06-22
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

HIGH PERFORMANCE CALIBRATORS 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 1988-06-22 under 510(k) number K875216. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH PERFORMANCE CALIBRATORS?

HIGH PERFORMANCE CALIBRATORS is a medical device that received FDA 510(k) clearance on 1988-06-22. The listed applicant is Rapid Diagnostic Laboratories, Inc.. The 510(k) number is K875216.

When did HIGH PERFORMANCE CALIBRATORS receive FDA 510(k) clearance?

HIGH PERFORMANCE CALIBRATORS received FDA 510(k) clearance on 1988-06-22, under 510(k) number K875216.

Who is the listed applicant for HIGH PERFORMANCE CALIBRATORS?

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 HIGH PERFORMANCE CALIBRATORS?

The FDA product code for HIGH PERFORMANCE CALIBRATORS is DKB.

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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 CONTROLK871694HYPERFORMANCE CONTROLS (HP-CONTROLS)K863117HIGH PERFORMANCE CANNABINOID CONTROLSK850139COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER

Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)Dade Behring, 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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