Indications for Use
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and PDF)
510(k) Number (if known): ___________
Device Name: ________________________________________________
Indications for Use:
Prescription Use _______
(Part 21 CFR 801 Subpart D) |
AND/OR |
Over-The-Counter Use _______
(21 CFR 801 Subpart C)
|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic
Devices (OIVD)
______________________________
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)____________________
Page 1 of ___
|
