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510(k) K964781

IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT by Beckman Instruments, Inc. — Product Code DDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
November 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prealbumin, Fitc, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5060
Review Panel
IM
Submission Type

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Other clearances for product code DDS

  • K972812 — RAICHEM PREALBUMIN SPIA (August 28, 1997)
  • K934966 — SPQ PAL CONTROL LEVEL II (January 11, 1994)
  • K854811 — ICS PAB PREALBUMIN REAGENT TEST KIT (January 24, 1986)