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FDA 510(k)

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

K-Number: K991733 · 1999-07-13

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1999-07-13
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1999-07-13 under 510(k) number K991733. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS?

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS is a medical device that received FDA 510(k) clearance on 1999-07-13. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K991733.

When did ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS receive FDA 510(k) clearance?

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS received FDA 510(k) clearance on 1999-07-13, under 510(k) number K991733.

Who is the listed applicant for ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS?

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

What is the FDA product code for ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS?

The FDA product code for ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS is MRR.

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Other records listing Schiapparelli Biosystems, Inc. as applicant

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Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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