Atlas FDA

VIRON(TM)

FDA 510(k) clearance K872646 · decided 1987-09-14

Clearance details

K-number
K872646
Device name
VIRON(TM)
Applicant
bioMerieux, Inc.
Decision
Substantially Equivalent
Date received
1987-07-06
Decision date
1987-09-14
Days to decision
70 days
Clearance type
Traditional
Product code
JJT
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Easton, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
THXID™-BRAF (P120014/S012)bioMerieux, Inc.2021-12-20
THxID-BRAF kit (P120014/S011)bioMerieux, Inc.2021-03-10
THxID-BRAF assay kit (P120014/S010)bioMerieux, Inc.2020-02-26
THxID BRAF assay kit (P120014/S009)bioMerieux, Inc.2019-08-26
THxID BRAF assay kit (P120014/S008)bioMerieux, Inc.2018-06-27
THxID-BRAF kit (P120014/S007)bioMerieux, Inc.2016-11-22
VIDAS TOTAL PSA (P040008/S013)bioMerieux, Inc.2016-05-31
THXID-BRAF KIT (P120014/S006)bioMerieux, Inc.2016-04-05