Thermo Scientific BRAHMS KRYPTOR compact PLUS - Page 53

Page
2
-
This
letter
will
allow
you
to
begin
marketing
your
device
as
described
in
your
Section
5
10(k)
premarket
notification.
The
FDA
finding
of
substantial
equivalence
of
your
device
to
a
legally
marketed
predicate
device
results
in
a
classification
for
your
device
and
thus,
permits
your
device
to
proceed
to
the
market.
If
you
desire
specific
advice
for
your
device
on
our
labeling
regulation
(21
CFR
Part
801),
please
contact
the
Office
of
In
Vitro
Diagnostic
Device
Evaluation
and
Safety
at
240-276-0450.
Also,
please
note
the
regulation
entitled,
"Misbranding
by
reference
to
premarket
notification"
(21CFR
Part
807.97).
For
questions
regarding
postmarket
surveillance,
please
contact
CDRH's
Office
of
Surveillance
and
Biometric's
(OSB's)
Division
of
Postmarket
Surveillance
at
240-276-3474.
For
questions
regarding
the
reporting
of
device
adverse:
events
(Medical
Device
Reporting
(MDR)),
please
contact
the
Division
of
Surveillance
Systems
at
240-276-3464.
You
may
obtain
other
general
information
on
your
responsibilities
under
the
Act
from
the
Division
of
Small
Manufacturers,
International
and
Consumer
Assistance
at
its
toll-free
number
(800)
638-2041
or
(240)
276-3150
or
at
its
Internet
address
http://www.fda.gov/cdrh/industrV/support/index.html.
Sincerely
yours,
Sally
A.
Hojvat,
M.Sc.,
Ph.D.
Director
Division
of
Microbiology
Devices
Office
of
In
Vitro
Diagnostic
Device
Evaluation
and
Safety
Center
for
Devices
and
Radiological
Health
Enclosure