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510(k) K880828

WAKO(TM) IGM-HA DIRECT by Wako Chemicals USA, Inc. — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1988
Date Received
March 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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  • K894417 — RAICHEM(TM) SPIA(TM) IGM REAGENTS (August 2, 1989)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K873871 — IMMUNOGLOBULINS M (October 13, 1987)
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  • K871498 — TITAN GEL IMMUNOFIX CONTROLS (April 29, 1987)