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

Device, Microtiter Diluting/Dispensing

21 CFR 866.2500 / Microbiology
FDA source (opens on fda.gov)

JTC is the FDA product code for Device, Microtiter Diluting/Dispensing, a class I device type, regulated under 21 CFR 866.2500. As of , FDA records hold 66 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
JTC
Device name
Device, Microtiter Diluting/Dispensing
Regulation
21 CFR 866.2500
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
66
Ingested recalls
9

Clearances, product code JTC

By decision year
66 clearances under product code JTC with a decision year between 1976 and 1992, 1985 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code JTC by decision year
YearClearances
19761
19782
19795
19805
198111
19825
19836
19842
198512
19865
19873
19882
19895
19901
19921

Applicants with the most clearances

Product code JTC
Applicants holding the most 510(k) clearances under product code JTC
ApplicantClearances
Dynatech Laboratories, Inc.12
Dynatech Corp.6
Corning Costar Corp.5
Flow Laboratories, Inc.5
Genetic Systems Corp.4
bioMerieux, Inc.4
Bio-Tek Instruments, Inc.3
Hamilton Co3
Plastic Injectors, Inc.3
Skatron, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order