CYTOVISION FOR CEP XY

Device, Automated Cell-locating

APPLIED IMAGING CORP.

The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Cytovision For Cep Xy.

Pre-market Notification Details

• Device ID: K042542
• 510k Number: K042542
• Device Name: CYTOVISION FOR CEP XY
• Classification: Device, Automated Cell-locating
• Applicant: APPLIED IMAGING CORP. 120 BAYTECH DRIVE San Jose, CA 95134 -2302
• Contact: Diane C Day
• Correspondent: Diane C Day; APPLIED IMAGING CORP. 120 BAYTECH DRIVE San Jose, CA 95134 -2302
• Product Code: JOY
• CFR Regulation Number: 864.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-20
• Decision Date: 2005-01-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00849832013426	K042542	000
00849832012146	K042542	000
00849832012153	K042542	000
00849832012160	K042542	000
00849832012177	K042542	000
00849832012184	K042542	000
00849832012191	K042542	000
00849832012207	K042542	000
00849832013181	K042542	000
00849832012139	K042542	000
00849832011637	K042542	000
00849832013495	K042542	000
00849832010821	K042542	000
00849832010920	K042542	000
00849832011446	K042542	000
00849832011453	K042542	000
00849832011460	K042542	000
00849832011477	K042542	000
00849832011484	K042542	000
00849832013198	K042542	000
00849832013204	K042542	000
00849832013334	K042542	000
00849832013358	K042542	000
00849832013365	K042542	000
00849832013372	K042542	000
00849832013389	K042542	000
00849832013396	K042542	000
00849832013402	K042542	000
00849832013419	K042542	000
00849832013327	K042542	000
00849832013310	K042542	000
00849832013211	K042542	000
00849832013235	K042542	000
00849832013242	K042542	000
00849832013259	K042542	000
00849832013266	K042542	000
00849832013273	K042542	000
00849832013280	K042542	000
00849832013297	K042542	000
00849832013488	K042542	000