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FDA 510(k)

DRUG STANDARD SET

K-Number: K884177 · 1989-02-17

ApplicantGelman Sciences, Inc.
Decision Date1989-02-17
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUG STANDARD SET is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K884177. 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 STANDARD SET?

DRUG STANDARD SET is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K884177.

When did DRUG STANDARD SET receive FDA 510(k) clearance?

DRUG STANDARD SET received FDA 510(k) clearance on 1989-02-17, under 510(k) number K884177.

Who is the listed applicant for DRUG STANDARD SET?

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

What is the FDA product code for DRUG STANDARD SET?

The FDA product code for DRUG STANDARD SET is DKB.

Related Clinical Trials

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.

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Other records listing Gelman Sciences, 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.

K946190DRUG DISPENSING SPIKEK943127PHARMASSURE LARGE VOLUME TRANSFER FILTERSK941589SYRINGE FILTER DEVICESK941020DRUG RECONSTITUTION FILTER DEVICEK942275VIAL VENT FILTERK941032UNKNOWN

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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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