20 results
424B3
BIAF
BioAffinity Technologies Inc
16 Apr 24
Prospectus supplement
7:19pm
monetary penalties;
recall, detention, or seizure of products;
operating restrictions, partial or total shutdown of production facilities;
refusal … marketing and/or recall the modified device until 510(k) clearance or PMA approval is obtained.
De Novo Classification
Devices of a new type
POS AM
BIAF
BioAffinity Technologies Inc
1 Apr 24
Prospectus update (post-effective amendment)
8:06pm
orders;
injunctions, or consent decrees;
civil monetary penalties;
recall, detention, or seizure of products;
operating restrictions, partial or total … . The FDA also can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or PMA approval is obtained.
De
DRS
7p5fv4 wsqiqb2f
14 Aug 23
Draft registration statement
12:00am
8-K
EX-1.1
5c06ww8k0 v3pyj
6 Sep 22
Entry into a Material Definitive Agreement
1:15pm
424B4
4wplnwo
2 Sep 22
Prospectus supplement with pricing info
3:25pm
S-1
0chk1k
25 Apr 22
IPO registration
6:16am
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