Perceptive Systems Inc Psicom 217 Karyotyping Syst

FDA 510(k) K861974 · Perceptive Systems, Inc.

Substantially Equivalent

510(k) numberK861974

Submission

Device name
Perceptive Systems Inc Psicom 217 Karyotyping Syst
Applicant
Perceptive Systems, Inc.
Houston, TX, US
Received
May 21, 1986
Decision date
August 4, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LNJ – Analyzer, Chromosome, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5260
Specialty
Hematology

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K895095Aks IILNJ · Traditional Amoco Technology Co.02/09/1990SE
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K864955CytoscanLNJ · Traditional Image Recognition Systems , Ltd.03/16/1987SE
K851508Nikon/Joyce Lock Magican 2 Chromosome SysLNJ · Traditional Nikon, Inc.07/12/1985SE
K851174MetachromeLNJ · Traditional Potomac Medical System05/23/1985SE

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Questions and answers

When was Perceptive Systems Inc Psicom 217 Karyotyping Syst cleared by the FDA?

Perceptive Systems Inc Psicom 217 Karyotyping Syst (K861974) received a 510(k) decision of Substantially Equivalent on August 4, 1986, 75 days after the submission was received.

What is the product code of K861974?

The FDA product code is LNJ – Analyzer, Chromosome, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5260.