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FDA 510(k)

DRUG STANDARDS

K-Number: K833276 · 1984-01-01

ApplicantSupelco, Inc.
Decision Date1984-01-01
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUG STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Supelco, Inc.. It received FDA 510(k) clearance on 1984-01-01 under 510(k) number K833276. 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 DRUG STANDARDS?

DRUG STANDARDS is a medical device that received FDA 510(k) clearance on 1984-01-01. The listed applicant is Supelco, Inc.. The 510(k) number is K833276.

When did DRUG STANDARDS receive FDA 510(k) clearance?

DRUG STANDARDS received FDA 510(k) clearance on 1984-01-01, under 510(k) number K833276.

Who is the listed applicant for DRUG STANDARDS?

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

What is the FDA product code for DRUG STANDARDS?

The FDA product code for DRUG STANDARDS is DKB.

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Other records listing Supelco, 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.

K894141LIQUID CHROMATOGRAPHY COLUMNSK884403LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBEK883615LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73K881868LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARDK881361SOLID PHASE EXTRACTION TUBESK880724LIQUID CHROMATO. COLUMNS

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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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