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510(k) K810221

SCRIPPSERA THEUMATOID FACTOR REFER. CNTL by Scripps-Miles, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1981
Date Received
January 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
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)
  • K810081 — SCRIPPSERA ANA REFERENCE CONTROL SERA (February 9, 1981)

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