Laser-Cal

FDA 510(k) K811063 · Diagnostic Technology, Inc.

Substantially Equivalent

510(k) numberK811063

Submission

Device name
Laser-Cal
Applicant
Diagnostic Technology, Inc.
Mchenry, IL, US
Received
April 17, 1981
Decision date
July 1, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KRX – Calibrator For Cell Indices
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8150
Specialty
Hematology

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More from Clinical Diagnostic Solutions, Inc.

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K896378Lyme-Check(Tm) Test KitLSR · Traditional 11/05/1991SE
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K891542Ebna-Check(Tm) Test KitLLM · Traditional 06/20/1989SE
K890819Hsv-Check(Tm) Test KitHIS · Traditional 06/20/1989SE
K890639Resubmitted Ebv/Igm-Check Test KitLJN · Traditional 06/20/1989SE
K871373Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional 06/25/1987SE
K864128Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional 04/29/1987SE
K863408Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional 11/28/1986SE
K860586PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional 05/07/1986SE
K860166Picoscale Blood Cell Counter, Model PS-5GKL · Traditional 04/04/1986SE

Questions and answers

When was Laser-Cal cleared by the FDA?

Laser-Cal (K811063) received a 510(k) decision of Substantially Equivalent on July 1, 1981, 75 days after the submission was received.

What is the product code of K811063?

The FDA product code is KRX – Calibrator For Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8150.