510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GRTClass I

Antiserum, Fluorescent, Mycobacterium Tuberculosis

21 CFR 866.3370 / Microbiology
FDA source (opens on fda.gov)

GRT is the FDA product code for Antiserum, Fluorescent, Mycobacterium Tuberculosis, a class I device type, regulated under 21 CFR 866.3370. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
GRT
Device name
Antiserum, Fluorescent, Mycobacterium Tuberculosis
Regulation
21 CFR 866.3370
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code GRT

By decision year
1 clearance under product code GRT with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GRT by decision year
YearClearances
19791

Applicants with the most clearances

Product code GRT
Applicants holding the most 510(k) clearances under product code GRT
ApplicantClearances
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code