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510(k) K843794

LATEX-R RICKETTSII by Health Research, Inc. — Product Code GPP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1985
Date Received
September 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Rocky Mountain Spotted Fever
Device Class
Class I
Regulation Number
866.3500
Review Panel
MI
Submission Type

Other clearances by Health Research, Inc.

  • K872129 — LATEX R. CONORII (August 19, 1987)
  • K860557 — LATEX R. TYPHI (April 21, 1986)