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510(k) K811714

HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT by Scripps-Miles, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 17, 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)
  • K811433 — SCRIPPSERA COMPLEMENT CONTROL SERA (June 16, 1981)
  • K810501 — SCRIPPSYSTEM C3 RID KIT (April 8, 1981)
  • K810502 — SCRIPPSYSTEM C4 RID KIT (April 8, 1981)
  • K810221 — SCRIPPSERA THEUMATOID FACTOR REFER. CNTL (February 9, 1981)
  • K810141 — SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT (February 9, 1981)
  • K810081 — SCRIPPSERA ANA REFERENCE CONTROL SERA (February 9, 1981)

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