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

Container, Specimen Mailer And Storage, Sterile

21 CFR 864.3250 / Pathology
FDA source (opens on fda.gov)

KDT is the FDA product code for Container, Specimen Mailer And Storage, Sterile, a class I device type, regulated under 21 CFR 864.3250. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
KDT
Device name
Container, Specimen Mailer And Storage, Sterile
Regulation
21 CFR 864.3250
Device class
Class I
Review panel
Pathology
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
17

Clearances, product code KDT

By decision year
12 clearances under product code KDT with a decision year between 1977 and 1987, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KDT by decision year
YearClearances
19771
19801
19811
19823
19832
19842
19861
19871

Applicants with the most clearances

Product code KDT
Applicants holding the most 510(k) clearances under product code KDT
ApplicantClearances
Preventive Diagnostics Corp.2
Sage Products LLC2
American Scientific Products1
Biosure, Inc.1
Dynatech Corp.1
Hospal Medical Corp.1
M.M. Wolfred, Ph.D.1
Perkins Mfg. Co.1
Richard-Allan Medical Ind., Inc.1
Xsirius Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 104 companies shown, in name order