Consed Fecal Concentration System

FDA 510(k) K884755 · Donald L. Price, Ph.D.

Substantially Equivalent

510(k) numberK884755

Submission

Device name
Consed Fecal Concentration System
Applicant
Donald L. Price, Ph.D.
Bradenton, FL, US
Received
November 14, 1988
Decision date
January 10, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IFP – Formalin, Neutral Buffered
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code IFP

510(k)DeviceApplicantDecision
K872663Dry-FormIFP · Traditional Anatech, Ltd.08/06/1987SE
K872140(Msi) Path-SaverIFP · Traditional Medical Specialties, Inc.06/15/1987SE
K870852NBF 10% Neutral Buffered FormalinIFP · Traditional Anatech, Ltd.03/31/1987SE
K853497Prefilled Specimen Jars 10% Neutral Buf-FormalinIFP · Traditional Surgipath Medical Industries, Inc.08/28/1985SE
K842982Formalin BufferedIFP · Traditional Reagent Laboratory, Inc.10/01/1984SE
K842940Cba FormalinIFP · Traditional Anatech, Ltd.08/28/1984SE
K842728Buf-FixIFP · Traditional E K Ind., Inc.08/03/1984SE
K840926Formalin Solution 10% Neutral BufferIFP · Traditional Sigma Chemical Co.03/12/1984SE
K830583Neutral Buffered Formalin 10%IFP · Traditional Surgipath Medical Industries, Inc.03/17/1983SE
K830582Millonig's Modified Phosphate BufferedIFP · Traditional Surgipath Medical Industries, Inc.03/17/1983SE

Questions and answers

When was Consed Fecal Concentration System cleared by the FDA?

Consed Fecal Concentration System (K884755) received a 510(k) decision of Substantially Equivalent on January 10, 1989, 57 days after the submission was received.

What is the product code of K884755?

The FDA product code is IFP – Formalin, Neutral Buffered, a Class I (low risk) device regulated under 21 CFR 864.4010.