Aptt Reagent

FDA 510(k) K904341 · Sigma Chemical Co.

Substantially Equivalent

510(k) numberK904341

Submission

Device name
Aptt Reagent
Applicant
Sigma Chemical Co.
St. Louis, MO, US
Received
September 20, 1990
Decision date
November 8, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GFO – Activated Partial Thromboplastin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7925
Specialty
Hematology

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K022021Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional Vital Scientific N.V.11/01/2002SE
K014028Careside ApttGFO · Traditional Careside Hemotology, Inc.02/08/2002SE
K014008Hemochron Jr. Citrate Aptt CuvetteGFO · Special Itc, Inc.01/24/2002SE
K992712Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional Sigma Diagnostics, Inc.12/06/1999SE

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K933679Sigma Bun ReagentLFP · Traditional 12/17/1993SE
K933703Sigma Wash Concentrate SolutionJJE · Traditional 12/10/1993SE
K933692Sigma CO2 Acid ReagentJFL · Traditional 12/09/1993SE
K933695Sigma Electrolyte BufferJFL · Traditional 10/22/1993SE
K933697Sigma Cre ReagentCGX · Traditional 10/18/1993SE
K933693Sigma CX-3 Calibration Standard Level 2JIX · Traditional 10/13/1993SE

Questions and answers

When was Aptt Reagent cleared by the FDA?

Aptt Reagent (K904341) received a 510(k) decision of Substantially Equivalent on November 8, 1990, 49 days after the submission was received.

What is the product code of K904341?

The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.