Sample Identification Station Model 38010

FDA 510(k) K884269 · Icn Micromedic Systems

Substantially Equivalent

510(k) numberK884269

Submission

Device name
Sample Identification Station Model 38010
Applicant
Icn Micromedic Systems
Horsham, PA, US
Received
October 11, 1988
Decision date
January 9, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJJ – Counter (Beta, Gamma) For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2320
Specialty
Clinical Chemistry

Other 510(k)s with product code JJJ

510(k)DeviceApplicantDecision
K962762Sequential Sample Multi-Photon DetectorJJJ · Traditional Biotraces, Inc.08/16/1996SE
K946387Capra (Caprac-R) Wipetest and Well CounterJJJ · Traditional Capintec, Inc.03/30/1995SE
K920559Abbott Vertex AnalyzerJJJ · Traditional Abbott Laboratories03/19/1992SE
K900087Genesys 6000 Gamma CounterJJJ · Traditional Laboratory Technologies, Inc.07/19/1990SE
K896202MATRIX(TM)-96JJJ · Traditional Canberra Industries, Inc.01/02/1990SE
K894902SourcererJJJ · Traditional Oakfield Instruments, Ltd.10/17/1989SE
K884091SourcererJJJ · Traditional John Caunt Scientific , Ltd.02/02/1989SE
K8740941205 Betaplate Liquid Scintillation CounterJJJ · Traditional Lkb Instruments, Inc.11/04/1987SE
K872430Iso-Data 500 Series Gamma CounterJJJ · Traditional Iso-Data, Inc.08/21/1987SE
K872429Iso-Data 100 Series Gamma CounterJJJ · Traditional Iso-Data, Inc.08/21/1987SE

More from Iso-Data, Inc.

510(k)DeviceDecision
K883746Micromedic Ferritin Irma KitDBF · Traditional 10/27/1988SE
K880674Micromedic Crackpot Ria KitKLN · Traditional 10/06/1988SE
K881102Micromedic Morphine Ria KitDOE · Traditional 06/24/1988SE

Questions and answers

When was Sample Identification Station Model 38010 cleared by the FDA?

Sample Identification Station Model 38010 (K884269) received a 510(k) decision of Substantially Equivalent on January 9, 1989, 90 days after the submission was received.

What is the product code of K884269?

The FDA product code is JJJ – Counter (Beta, Gamma) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2320.