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510(k) K810081

SCRIPPSERA ANA REFERENCE CONTROL SERA by Scripps-Miles, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1981
Date Received
January 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Scripps-Miles, Inc.

  • K812453 — SCRIPPSYSTEM IMMUNOGLOBIN RID KIT (September 23, 1981)
  • K812328 — SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT (September 8, 1981)
  • K811714 — HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT (July 10, 1981)
  • K811433 — SCRIPPSERA COMPLEMENT CONTROL SERA (June 16, 1981)
  • K810501 — SCRIPPSYSTEM C3 RID KIT (April 8, 1981)
  • K810502 — SCRIPPSYSTEM C4 RID KIT (April 8, 1981)
  • K810141 — SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT (February 9, 1981)
  • K810221 — SCRIPPSERA THEUMATOID FACTOR REFER. CNTL (February 9, 1981)

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