Test System Tissue Cell Culture Slide

FDA 510(k) K781516 · Zeus Scientific, Inc.

Substantially Equivalent

510(k) numberK781516

Submission

Device name
Test System Tissue Cell Culture Slide
Applicant
Zeus Scientific, Inc.
Mchenry, IL, US
Received
August 31, 1978
Decision date
September 27, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KIY – Chamber, Slide Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

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Questions and answers

When was Test System Tissue Cell Culture Slide cleared by the FDA?

Test System Tissue Cell Culture Slide (K781516) received a 510(k) decision of Substantially Equivalent on September 27, 1978, 27 days after the submission was received.

What is the product code of K781516?

The FDA product code is KIY – Chamber, Slide Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.