Isogel Agarose

FDA 510(k) K841407 · Fmc Corp.

Substantially Equivalent

510(k) numberK841407

Submission

Device name
Isogel Agarose
Applicant
Fmc Corp.
Walker, MI, US
Received
April 4, 1984
Decision date
July 16, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJN – Apparatus, Electrophoresis, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2485
Specialty
Clinical Chemistry

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K881852Rep SP Electrophoresis System Cat No. 3170JJN · Traditional Helena Laboratories07/08/1988SE
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K873352Rapid Electrophoresis System (Rep)JJN · Traditional Helena Laboratories09/08/1987SE
K864436Stavip 3000JJN · Traditional Roseburg SA03/16/1987SE
K861414Electrophoresis Work Center (Ewc)JJN · Traditional Helena Laboratories08/26/1986SE
K844710Eurochima Serum Protein Electrophoresis MethodJJN · Traditional Logos Scientific, Inc.01/07/1985SE
K842560OPTIPHOR-10JJN · Traditional Gelman Sciences, Inc.08/10/1984SE

More from Gelman Sciences, Inc.

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Questions and answers

When was Isogel Agarose cleared by the FDA?

Isogel Agarose (K841407) received a 510(k) decision of Substantially Equivalent on July 16, 1985, 468 days after the submission was received.

What is the product code of K841407?

The FDA product code is JJN – Apparatus, Electrophoresis, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2485.