22 results
424B3
BIAF
bioAffinity Technologies, Inc.
23 Sep 24
Prospectus supplement
4:00pm
penalties;
recall, detention, or seizure of products;
operating restrictions, partial or total shutdown of production facilities;
refusal of or delay … and/or recall the modified device until 510(k) clearance or PMA approval is obtained.
De Novo Classification
Devices of a new type that the FDA has
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
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14 Aug 23
Draft registration statement
12:00am
8-K
EX-1.1
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6 Sep 22
Entry into a Material Definitive Agreement
1:15pm
424B4
7t17tp6om7zg4
2 Sep 22
Prospectus supplement with pricing info
3:25pm