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FDA 510(k)

IL TEST CALIBRATION SET APO A1B

K-Number: K923079 · 1993-02-05

ApplicantInstrumentation Laboratory CO
Decision Date1993-02-05
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IL TEST CALIBRATION SET APO A1B is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1993-02-05 under 510(k) number K923079. 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 IL TEST CALIBRATION SET APO A1B?

IL TEST CALIBRATION SET APO A1B is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K923079.

When did IL TEST CALIBRATION SET APO A1B receive FDA 510(k) clearance?

IL TEST CALIBRATION SET APO A1B received FDA 510(k) clearance on 1993-02-05, under 510(k) number K923079.

Who is the listed applicant for IL TEST CALIBRATION SET APO A1B?

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

What is the FDA product code for IL TEST CALIBRATION SET APO A1B?

The FDA product code for IL TEST CALIBRATION SET APO A1B is DFC.

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Other records listing Instrumentation Laboratory CO as applicant

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Related Devices (Code: DFC)

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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

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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