Lkb-Bromma 2188 Ultrotome Nova

FDA 510(k) K812158 · Lkb Instruments, Inc.

Substantially Equivalent

510(k) numberK812158

Submission

Device name
Lkb-Bromma 2188 Ultrotome Nova
Applicant
Lkb Instruments, Inc.
Mchenry, IL, US
Received
July 29, 1981
Decision date
September 16, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IDM – Microtome, Ultra
Device class
Class I (low risk)
Regulation
21 CFR 864.3010
Specialty
Pathology

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Questions and answers

When was Lkb-Bromma 2188 Ultrotome Nova cleared by the FDA?

Lkb-Bromma 2188 Ultrotome Nova (K812158) received a 510(k) decision of Substantially Equivalent on September 16, 1981, 49 days after the submission was received.

What is the product code of K812158?

The FDA product code is IDM – Microtome, Ultra, a Class I (low risk) device regulated under 21 CFR 864.3010.