510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LEDClass I

Stains, Chemical Solution

21 CFR 864.1850 / Hematology
FDA source (opens on fda.gov)

LED is the FDA product code for Stains, Chemical Solution, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LED
Device name
Stains, Chemical Solution
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
16
Ingested recalls
0

Clearances, product code LED

By decision year
16 clearances under product code LED with a decision year between 1981 and 2005, 1986 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code LED by decision year
YearClearances
19811
19832
19843
19852
19866
20021
20051

Applicants with the most clearances

Product code LED
Applicants holding the most 510(k) clearances under product code LED
ApplicantClearances
Cytocolor, Inc.5
Difco Laboratories, Inc.2
E K Ind., Inc.2
Sigma Chemical Co.2
American Scientific Products1
Devetec, Inc.1
Preventive Diagnostics Corp.1
Scandinavian Formulas, Inc.1
Sinclair Pharmaceuticals Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order