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510(k) K811433

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

K811433 is an FDA 510(k) premarket notification submitted by Scripps-Miles, Inc. for the device "SCRIPPSERA COMPLEMENT CONTROL SERA". The FDA issued a decision of Substantially Equivalent on June 16, 1981. The device falls under product code DHL (Protein, Complement, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.4100. Scripps-Miles, Inc. has at least 8 other 510(k) clearances on record.

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)
  • K810502 — SCRIPPSYSTEM C4 RID KIT (April 8, 1981)
  • K810501 — SCRIPPSYSTEM C3 RID KIT (April 8, 1981)
  • K810081 — SCRIPPSERA ANA REFERENCE CONTROL SERA (February 9, 1981)
  • K810221 — SCRIPPSERA THEUMATOID FACTOR REFER. CNTL (February 9, 1981)
  • K810141 — SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT (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)

FDA data resources