Atlas FDA

COAGUCHEK S SYSTEM, MODEL 2138280

FDA 510(k) clearance K994349 · decided 2000-09-06

Clearance details

K-number
K994349
Device name
COAGUCHEK S SYSTEM, MODEL 2138280
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
1999-12-23
Decision date
2000-09-06
Days to decision
258 days
Clearance type
Traditional
Product code
JPA
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
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Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 0439 recall (Z-0100-06)Roche Diagnostics Corp.2005-10-28

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