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

Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

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

KDW is the FDA product code for Container, Specimen Mailer And Storage, Temperature Controlled, Sterile, a class I device type, regulated under 21 CFR 864.3250. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KDW
Device name
Container, Specimen Mailer And Storage, Temperature Controlled, 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
4
Ingested recalls
0

Clearances, product code KDW

By decision year
4 clearances under product code KDW with a decision year between 1991 and 1997, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KDW by decision year
YearClearances
19911
19941
19951
19971

Applicants with the most clearances

Product code KDW
Applicants holding the most 510(k) clearances under product code KDW
ApplicantClearances
Doxtech, Inc.1
Gbf Medical Group1
Harry A. Schlakman1
Substance Abuse Specialties, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order