Immulik Stain Plate

FDA 510(k) K812497 · Immulok, Inc.

Substantially Equivalent

510(k) numberK812497

Submission

Device name
Immulik Stain Plate
Applicant
Immulok, Inc.
Mchenry, IL, US
Received
August 31, 1981
Decision date
September 23, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IEG – Table, Slide Warming
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Specialty
Pathology

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Questions and answers

When was Immulik Stain Plate cleared by the FDA?

Immulik Stain Plate (K812497) received a 510(k) decision of Substantially Equivalent on September 23, 1981, 23 days after the submission was received.

What is the product code of K812497?

The FDA product code is IEG – Table, Slide Warming, a Class I (low risk) device regulated under 21 CFR 864.3010.