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FDA 510(k)

ANTISERUM TO HUMAN APOLIPOPROTEIN B

K-Number: K850690 · 1985-11-01

ApplicantKent Laboratories, Inc.
Decision Date1985-11-01
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANTISERUM TO HUMAN APOLIPOPROTEIN B is the device name listed in this FDA 510(k) record. The listed applicant is Kent Laboratories, Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K850690. 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 ANTISERUM TO HUMAN APOLIPOPROTEIN B?

ANTISERUM TO HUMAN APOLIPOPROTEIN B is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Kent Laboratories, Inc.. The 510(k) number is K850690.

When did ANTISERUM TO HUMAN APOLIPOPROTEIN B receive FDA 510(k) clearance?

ANTISERUM TO HUMAN APOLIPOPROTEIN B received FDA 510(k) clearance on 1985-11-01, under 510(k) number K850690.

Who is the listed applicant for ANTISERUM TO HUMAN APOLIPOPROTEIN B?

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

What is the FDA product code for ANTISERUM TO HUMAN APOLIPOPROTEIN B?

The FDA product code for ANTISERUM TO HUMAN APOLIPOPROTEIN B is MSJ.

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Other records listing Kent Laboratories, 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.

K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITK951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITK951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITK950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITK85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

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Related Devices (Code: MSJ)

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.

K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral AtomicsK073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXDiazyme LaboratoriesK061377APOLIPOPROTEIN 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.

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