FDA 510(k)

THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL

K-Number: K851641 · 1985-07-23

Decision Date1985-07-23

Product CodeMSJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-07-23 under 510(k) number K851641. The device is classified under product code MSJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL?

THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL is a medical device that received FDA 510(k) clearance on 1985-07-23. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K851641.

When did THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL receive FDA 510(k) clearance?

THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL received FDA 510(k) clearance on 1985-07-23, under 510(k) number K851641.

Who is the listed applicant for THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL?

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

What is the FDA product code for THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL?

The FDA product code for THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL is MSJ.

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Other records listing Ortho Diagnostic Systems, Inc. as applicant

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Related Devices (Code: MSJ)

K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral Atomics K073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXDiazyme Laboratories K061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSPointe Scientific, Inc.,K063608DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSBeckman Instruments, Inc.

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.