VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34

FDA 510(k) clearance K100015 · decided 2011-08-09

Clearance details

K-number: K100015
Device name: VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
Applicant: Abbott Molecular, Inc.
Decision: Substantially Equivalent
Date received: 2010-01-04
Decision date: 2011-08-09
Days to decision: 582 days
Clearance type: Traditional
Product code: OVQ
Device class: 2
Regulation number: 866.6040
Medical specialty: Immunology
Advisory committee: Immunology
Location: Des Plaines, IL, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE (K962873)	Vysis	1997-01-13

No recalls on record reference this clearance.