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FDA 510(k)

DIAZYME LP(A) ASSAY

K-Number: K082488 · 2009-01-13

ApplicantGeneral Atomics
Decision Date2009-01-13
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIAZYME LP(A) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is General Atomics. It received FDA 510(k) clearance on 2009-01-13 under 510(k) number K082488. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME LP(A) ASSAY?

DIAZYME LP(A) ASSAY is a medical device that received FDA 510(k) clearance on 2009-01-13. The listed applicant is General Atomics. The 510(k) number is K082488.

When did DIAZYME LP(A) ASSAY receive FDA 510(k) clearance?

DIAZYME LP(A) ASSAY received FDA 510(k) clearance on 2009-01-13, under 510(k) number K082488.

Who is the listed applicant for DIAZYME LP(A) ASSAY?

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

What is the FDA product code for DIAZYME LP(A) ASSAY?

The FDA product code for DIAZYME LP(A) ASSAY is DFC.

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Other records listing General Atomics 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.

K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYK072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSK050178HBA1C ENZYMATIC ASSAYK042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITK033360DIAZYME LITHIUM ENZYMATIC ASSAY KIT

Related Devices (Code: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

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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