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SCEPTOR SYSTEM PANELS

FDA 510(k) clearance K950123 · decided 1995-03-23

Clearance details

K-number
K950123
Device name
SCEPTOR SYSTEM PANELS
Applicant
Becton Dickinson Microbiology Systems
Decision
Substantially Equivalent
Date received
1995-01-12
Decision date
1995-03-23
Days to decision
70 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Sparks, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.