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510(k) K941346

PLASMINOGEN RID TEST KIT by The Binding Site, Ltd. — Product Code DDX

K941346 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "PLASMINOGEN RID TEST KIT". The FDA issued a decision of Substantially Equivalent on September 9, 1994. The device falls under product code DDX (Plasminogen, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5715. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
March 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasminogen, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5715
Review Panel
HE
Submission Type

Other clearances by The Binding Site, Ltd.

  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)
  • K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (December 20, 2013)
  • K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (February 27, 2012)
  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MOD (December 30, 2009)
  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (February 10, 2009)
  • K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (December 19, 2008)

Other clearances for product code DDX

  • K884766 — BERICHROM(R) PLASMINOGEN (January 4, 1989)
  • K864212 — IL TEST 97573-15, PLASMINOGEN ASSAY (December 4, 1986)
  • K854572 — COATEST PLASMINOGEN (February 26, 1986)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)
  • K832591 — DIACROM *PLG (November 21, 1983)
  • K812625 — ACA PLASMINOGEN TEST PACK (September 29, 1981)
  • K811777 — HELENA PLASMINOGEN QUIPLATE PROCEDURE (July 2, 1981)
  • K781478 — PLASMINOGEN ASSAY (November 15, 1978)
  • K772085 — LAS-R HUMAN PLASMINOGEN TEST (January 24, 1978)

FDA data resources