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FDA 510(k)

IL TEST(TM) DAT CALIBRATOR A( -)

K-Number: K913739 · 1991-09-10

ApplicantInstrumentation Laboratory CO
Decision Date1991-09-10
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST(TM) DAT CALIBRATOR A( -) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1991-09-10 under 510(k) number K913739. 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 IL TEST(TM) DAT CALIBRATOR A( -)?

IL TEST(TM) DAT CALIBRATOR A( -) is a medical device that received FDA 510(k) clearance on 1991-09-10. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K913739.

When did IL TEST(TM) DAT CALIBRATOR A( -) receive FDA 510(k) clearance?

IL TEST(TM) DAT CALIBRATOR A( -) received FDA 510(k) clearance on 1991-09-10, under 510(k) number K913739.

Who is the listed applicant for IL TEST(TM) DAT CALIBRATOR A( -)?

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

What is the FDA product code for IL TEST(TM) DAT CALIBRATOR A( -)?

The FDA product code for IL TEST(TM) DAT CALIBRATOR A( -) is DKB.

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Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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

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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