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510(k) K030067

VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS by Ortho-Clinical Diagnostics — Product Code MJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2003
Date Received
January 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Serological, Positive Control
Device Class
Class I
Regulation Number
862.1660
Review Panel
MI
Submission Type

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Other clearances for product code MJX

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  • K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SER (March 10, 1997)
  • K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION (March 7, 1994)
  • K925703 — OPUS SEROLOGY CONTROLS (April 8, 1993)