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FDA 510(k)

ALFATEST

K-Number: K780542 · 1978-05-19

ApplicantPanmed, Inc.
Decision Date1978-05-19
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALFATEST is the device name listed in this FDA 510(k) record. The listed applicant is Panmed, Inc.. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780542. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALFATEST?

ALFATEST is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Panmed, Inc.. The 510(k) number is K780542.

When did ALFATEST receive FDA 510(k) clearance?

ALFATEST received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780542.

Who is the listed applicant for ALFATEST?

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

What is the FDA product code for ALFATEST?

The FDA product code for ALFATEST is LBR.

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Other records listing Panmed, Inc. as applicant

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Related Devices (Code: LBR)

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.

K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral AtomicsK050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco DiagnosticsK023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHemagen Diagnostics, Inc.K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan DiagnosticsK992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, 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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