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510(k) K811433

SCRIPPSERA COMPLEMENT CONTROL SERA by Scripps-Miles, Inc. — Product Code DHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1981
Date Received
May 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protein, Complement, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.4100
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)
  • 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)

Other clearances for product code DHL

  • K870351 — EZ COMPLEMENT REAGENTS, 78N2212 (March 13, 1987)
  • K811445 — KALLESTAD R QUANTIPLATE ALT. PATHWAY T. (June 24, 1981)
  • K770866 — RABBIT COMPLEMENT (June 3, 1977)