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

Kit, Quality Control For Culture Media

21 CFR 866.2480 / Microbiology
FDA source (opens on fda.gov)

JTR is the FDA product code for Kit, Quality Control For Culture Media, a class I device type, regulated under 21 CFR 866.2480. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 46 recalls.

Classification record

Product code
JTR
Device name
Kit, Quality Control For Culture Media
Regulation
21 CFR 866.2480
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
46

Clearances, product code JTR

By decision year
12 clearances under product code JTR with a decision year between 1981 and 1987, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JTR by decision year
YearClearances
19811
19823
19832
19842
19863
19871

Applicants with the most clearances

Product code JTR
Applicants holding the most 510(k) clearances under product code JTR
ApplicantClearances
Micro-Bio-Logics3
American Scientific Products1
American Type Culture Collection1
Austin Biological Laboratories1
Biological & Environmental Control Laboratories1
Lab Ability, Inc.1
Pro-Lab, Inc.1
Remel Co.1
Trend Scientific, Inc.1
Universal Micro Reference Laboratory1

Companies listing this code with FDA

Companies whose registered establishments list this code