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510(k) K812328

SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT by Scripps-Miles, Inc. — Product Code DEW

K812328 is an FDA 510(k) premarket notification submitted by Scripps-Miles, Inc. for the device "SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Scripps-Miles, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
August 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Scripps-Miles, Inc.

  • K812453 — SCRIPPSYSTEM IMMUNOGLOBIN RID KIT (September 23, 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)
  • K810221 — SCRIPPSERA THEUMATOID FACTOR REFER. CNTL (February 9, 1981)
  • K810081 — SCRIPPSERA ANA REFERENCE CONTROL SERA (February 9, 1981)

Other clearances for product code DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources