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FDA 510(k)

LIQUI-SERA TDM CALIBRATORS

K-Number: K834398 · 1984-02-03

ApplicantBiodiagnostic Intl
Decision Date1984-02-03
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LIQUI-SERA TDM CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Biodiagnostic Intl. It received FDA 510(k) clearance on 1984-02-03 under 510(k) number K834398. 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 LIQUI-SERA TDM CALIBRATORS?

LIQUI-SERA TDM CALIBRATORS is a medical device that received FDA 510(k) clearance on 1984-02-03. The listed applicant is Biodiagnostic Intl. The 510(k) number is K834398.

When did LIQUI-SERA TDM CALIBRATORS receive FDA 510(k) clearance?

LIQUI-SERA TDM CALIBRATORS received FDA 510(k) clearance on 1984-02-03, under 510(k) number K834398.

Who is the listed applicant for LIQUI-SERA TDM CALIBRATORS?

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

What is the FDA product code for LIQUI-SERA TDM CALIBRATORS?

The FDA product code for LIQUI-SERA TDM CALIBRATORS is DKB.

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Other records listing Biodiagnostic Intl 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.

K031296LIQUI-HEME GLYCO A1C ASSAYK881430LIQUI-SERA SERUM ALCOHOL CONTROLSK874459LIQUI-SERA SPINAL FLUID CONTROLK863849LIQUI-SERA COMBO LIGAND/TDM CONTROLSK853906LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)K853887LIQUI-SERA CHEM. MULTIPLE CALIBRATORS

View all 11 devices →

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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