510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NALClass II

Test, Immunoassay, Biosensor, Hcg

21 CFR 862.1155 / Clinical Chemistry
FDA source (opens on fda.gov)

NAL is the FDA product code for Test, Immunoassay, Biosensor, Hcg, a class II device type, regulated under 21 CFR 862.1155. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NAL
Device name
Test, Immunoassay, Biosensor, Hcg
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code NAL

By decision year
2 clearances under product code NAL with a decision year between 1999 and 2002, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NAL by decision year
YearClearances
19991
20021

Applicants with the most clearances

Product code NAL
Applicants holding the most 510(k) clearances under product code NAL
ApplicantClearances
Quantech, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NAL.