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510(k) K810502

SCRIPPSYSTEM C4 RID KIT by Scripps-Miles, Inc. — Product Code DBI

K810502 is an FDA 510(k) premarket notification submitted by Scripps-Miles, Inc. for the device "SCRIPPSYSTEM C4 RID KIT". The FDA issued a decision of Substantially Equivalent on April 8, 1981. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Scripps-Miles, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1981
Date Received
February 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C4, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
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)
  • 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 DBI

  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM (November 29, 2001)
  • K010325 — WAKO AUTOKIT C4 (June 25, 2001)
  • K000468 — RANDOX COMPLEMENT C4 (March 27, 2000)
  • K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE (March 1, 2000)
  • K981785 — C4 MININEPH ANTISERUM (December 20, 1999)
  • K993481 — K-ASSAY C4 (November 29, 1999)
  • K983356 — C4 (November 4, 1998)
  • K964297 — N-ASSAY TIA C4 TEST KIT (July 14, 1997)
  • K964300 — N-ASSAY TIA MULTI V-NL (July 14, 1997)

FDA data resources