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

Solution, Decalcifier, Acid Containing

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

KDX is the FDA product code for Solution, Decalcifier, Acid Containing, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KDX
Device name
Solution, Decalcifier, Acid Containing
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code KDX

By decision year
8 clearances under product code KDX with a decision year between 1981 and 1987, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KDX by decision year
YearClearances
19812
19822
19842
19851
19871

Applicants with the most clearances

Product code KDX
Applicants holding the most 510(k) clearances under product code KDX
ApplicantClearances
E K Ind., Inc.1
Fisher Scientific Company L.L.C.1
Lerner Laboratories, Inc.1
Richard-Allan Medical Ind., Inc.1
Stephens Scientific1
Surgipath1
Surgipath Medical Industries, Inc.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order