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FDA 510(k)

MULTICHEM HDL PRECIPITATING REAGENT #S0914

K-Number: K874820 · 1988-01-07

ApplicantSimmler, Inc.
Decision Date1988-01-07
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTICHEM HDL PRECIPITATING REAGENT #S0914 is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1988-01-07 under 510(k) number K874820. 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 MULTICHEM HDL PRECIPITATING REAGENT #S0914?

MULTICHEM HDL PRECIPITATING REAGENT #S0914 is a medical device that received FDA 510(k) clearance on 1988-01-07. The listed applicant is Simmler, Inc.. The 510(k) number is K874820.

When did MULTICHEM HDL PRECIPITATING REAGENT #S0914 receive FDA 510(k) clearance?

MULTICHEM HDL PRECIPITATING REAGENT #S0914 received FDA 510(k) clearance on 1988-01-07, under 510(k) number K874820.

Who is the listed applicant for MULTICHEM HDL PRECIPITATING REAGENT #S0914?

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

What is the FDA product code for MULTICHEM HDL PRECIPITATING REAGENT #S0914?

The FDA product code for MULTICHEM HDL PRECIPITATING REAGENT #S0914 is LBR.

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Other records listing Simmler, 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.

K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBINK874049MULTICHEM ALBUMIN REAGENT S0902

View all 23 devices →

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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