Atlas FDA

INSTACCULT

FDA 510(k) clearance K002930 · decided 2001-01-22

Clearance details

K-number
K002930
Device name
INSTACCULT
Applicant
Medtek Diagnostics, LLC
Decision
Substantially Equivalent
Date received
2000-09-20
Decision date
2001-01-22
Days to decision
124 days
Clearance type
Traditional
Product code
KHE
Device class
2
Regulation number
864.6550
Medical specialty
Hematology
Advisory committee
Hematology
Location
Research Triangle Park, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.