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Found 2 results

510(k) Data Aggregation

K Number

Device Name

ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK

Manufacturer

ROCHE DIAGNOSTICS CORP.

Date Cleared

2005-09-08

(113 days)

Product Code

NEO, JIT, JJX

Regulation Number

862.1050

Why did this record match?

Product Code :

NEO

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

Manufacturer

OSTEOMETER BIOTECH A/S

Date Cleared

2001-05-16

(175 days)

Product Code

NEO

Regulation Number

862.1050

Why did this record match?

Product Code :

NEO

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

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