Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

Our Lactoferrin test may be a Class 1 test since December 22nd, 2023. (Class 1 = Waived)

Replying to a previous post where I provided links to FDA database for our 510K tests.

Pages to both tests show they were updated December 22nd, 2023.

The link to the Lactoferrin Test seems to indicate a Class 1 test.

Click on the Lactoferrin link.
Click on the link to section Sec. 866.5570
Lactoferrin immunological test system.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.


The IgE test still appears to be a Class 2 test, but that page was last updated on 03-11-2024.
Searching on new information for IgE now.

510(k) Number K934473
Device Name
LACTOFERRIN MICROASSAY SYSTEM
Date Received 09/14/1993
Decision Date 12/03/1993

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K934473

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510(k) Number. K991316
Device Name
TOUCH TEAR IGE MICROASSAY KIT
Date Received 04/19/1999
Decision Date 08/09/1999

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991316

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Applicant
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
RALEIGH, NC 27615