Flipscreen (TM) Total E Immunoassay

FDA 510(k) K885307 · Alerchek, Inc.

Substantially Equivalent

510(k) numberK885307

Submission

Device name
Flipscreen (TM) Total E Immunoassay
Applicant
Alerchek, Inc.
Portland, ME, US
Received
December 27, 1988
Decision date
March 8, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DGC – Ige, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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More from Adiatec SA

510(k)DeviceDecision
K874802Flipscreen QatDHB · Traditional 02/17/1988SE
K860027Flipscreen Specific E (Pe, Se, Ne, SW, NW) AssayDHB · Traditional 04/22/1986SE

Questions and answers

When was Flipscreen (TM) Total E Immunoassay cleared by the FDA?

Flipscreen (TM) Total E Immunoassay (K885307) received a 510(k) decision of Substantially Equivalent on March 8, 1989, 71 days after the submission was received.

What is the product code of K885307?

The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.