Atlas FDA

AD PERFECT

FDA 510(k) clearance K940768 · decided 1995-02-17

Clearance details

K-number
K940768
Device name
AD PERFECT
Applicant
Chimera Research & Chemical, Inc.
Decision
Substantially Equivalent
Date received
1994-02-18
Decision date
1995-02-17
Days to decision
364 days
Clearance type
Traditional
Product code
IFT
Device class
1
Regulation number
864.4010
Medical specialty
Pathology
Advisory committee
Pathology
Location
Seminole, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.