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510(k) K760146

SERUM, IGA GOAT ANTI-HUMAN ACID by Oxford Laboratories, Inc. — Product Code CZP

K760146 is an FDA 510(k) premarket notification submitted by Oxford Laboratories, Inc. for the device "SERUM, IGA GOAT ANTI-HUMAN ACID". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code CZP (Iga, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. 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
Iga, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Oxford Laboratories, Inc.

  • K780912 — ADJUSTABLE DISPENSOR (June 28, 1978)
  • 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)
  • K760148 — SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN (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 CZP

  • K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Im (June 26, 2020)
  • K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (February 13, 2006)
  • K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (March 10, 2004)
  • K024038 — N LATEX IGA (February 13, 2003)
  • K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (January 14, 2000)
  • K983359 — IGA (November 4, 1998)
  • K962200 — QUANTEX IGA (September 25, 1996)
  • K955794 — IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K955907 — BOEHRINGER MANNHEIM IGA ASSAY (February 9, 1996)
  • K952309 — N LATEX IGA (June 20, 1995)

FDA data resources