Atlas FDA

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE

FDA 510(k) clearance K021110 · decided 2002-06-06

Clearance details

K-number
K021110
Device name
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
Applicant
Dade Microscan, Inc.
Decision
Substantially Equivalent
Date received
2002-04-05
Decision date
2002-06-06
Days to decision
62 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.