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FDA 510(k)

CONTROL AND LINEARITY

K-Number: K910881 · 1991-09-13

ApplicantGds Diagnostics
Decision Date1991-09-13
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CONTROL AND LINEARITY is the device name listed in this FDA 510(k) record. The listed applicant is Gds Diagnostics. It received FDA 510(k) clearance on 1991-09-13 under 510(k) number K910881. 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 CONTROL AND LINEARITY?

CONTROL AND LINEARITY is a medical device that received FDA 510(k) clearance on 1991-09-13. The listed applicant is Gds Diagnostics. The 510(k) number is K910881.

When did CONTROL AND LINEARITY receive FDA 510(k) clearance?

CONTROL AND LINEARITY received FDA 510(k) clearance on 1991-09-13, under 510(k) number K910881.

Who is the listed applicant for CONTROL AND LINEARITY?

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

What is the FDA product code for CONTROL AND LINEARITY?

The FDA product code for CONTROL AND LINEARITY is DKB.

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Other records listing Gds Diagnostics 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.

K931257ACETASITEK910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDK891761GDS ENZYMATIC THEOPHYLLINE REAGENT

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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