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510(k) K760148

SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN by Oxford Laboratories, Inc. — Product Code CZW

K760148 is an FDA 510(k) premarket notification submitted by Oxford Laboratories, Inc. for the device "SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Oxford Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
June 29, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Oxford Laboratories, Inc.

  • K780912 — ADJUSTABLE DISPENSOR (June 28, 1978)
  • K760146 — SERUM, IGA GOAT ANTI-HUMAN ACID (July 20, 1976)
  • K760079 — REAGENT, THYROXINE T4 (#210) (July 20, 1976)
  • K760147 — SERUM, IGM ANTI-HUMAN ACID (July 20, 1976)
  • K760078 — REAGENT, RIA TRIIODOTHYRONINE T3 (#200) (July 20, 1976)
  • K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (July 20, 1976)
  • K760144 — SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID (July 20, 1976)
  • K760145 — SERUM, IGG GOAT ANTI-HUMAN ACID (July 19, 1976)

Other clearances for product code CZW

  • K100179 — SPAPLUS (August 13, 2010)
  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL (September 22, 2006)
  • K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (May 2, 2005)
  • K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMA (October 19, 2004)
  • K032796 — IBL C3D-CIC EIA TEST (January 13, 2004)
  • K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C (August 7, 2003)
  • K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM (November 29, 2001)
  • K010326 — WAKO AUTOKIT C3 (June 25, 2001)
  • K000469 — RANDOX COMPLEMENT C3 (March 27, 2000)

FDA data resources