Atlas FDA

ORTHO CLASSICAL PATHWAY COMPL. TEST

FDA 510(k) clearance K821898 · decided 1982-07-16

Clearance details

K-number
K821898
Device name
ORTHO CLASSICAL PATHWAY COMPL. TEST
Applicant
Ortho Diagnostic Systems, Inc.
Decision
Substantially Equivalent
Date received
1982-06-28
Decision date
1982-07-16
Days to decision
18 days
Clearance type
Traditional
Product code
DBA
Device class
2
Regulation number
866.5250
Medical specialty
Immunology
Advisory committee
Immunology
Location
Carpinteria, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.