Atlas FDA

OPUS CMV TEST SYSTEM-MODIFICATION

FDA 510(k) clearance K963084 · decided 1996-10-09

Clearance details

K-number
K963084
Device name
OPUS CMV TEST SYSTEM-MODIFICATION
Applicant
Behring Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1996-08-08
Decision date
1996-10-09
Days to decision
62 days
Clearance type
Traditional
Product code
LFZ
Device class
2
Regulation number
866.3175
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Westwood, MA, US
Third-party review
No
Expedited review
No

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IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (K993952)Diagnostic Products Corp.1999-12-16
SERAQUEST CMV IGM (K982485)Quest Intl., Inc.1999-01-13
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OPUS(R) CEA TEST SYSTEM (P920021/S001)Behring Diagnostics, Inc.1996-02-23