Atlas FDA

LED

16 FDA 510(k) clearances · Product code

23 daysmedian time to decision
69 days90th percentile
16clearances measured

FDA profile

Official device name
Stains, Chemical Solution
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Medical specialty
Hematology
Flags
GMP exempt
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SLIVASURE (K051409)Scandinavian Formulas, Inc.2005-08-08
SST SALIVA SUPPORTING TABLETS (K023046)Sinclair Pharmaceuticals, Ltd.2002-12-02
SPOTTEST CALCOFLUOR WHITE REAGENT (K860795)Difco Laboratories, Inc.1986-03-12
MEGACOLOR (K860319)Cytocolor, Inc.1986-02-20
NEUTROCOLOR (K860317)Cytocolor, Inc.1986-02-20
LYSOCOLOR (K860321)Cytocolor, Inc.1986-02-20
GRANULOCOLOR (K860320)Cytocolor, Inc.1986-02-20
PANOPTIKON (K860316)Cytocolor, Inc.1986-02-20
POLYCHROME IV STAIN (K854176)Devetec, Inc.1985-10-31
SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (K851481)Difco Laboratories, Inc.1985-04-29
GOMORI'S TRICHROME STAIN (K842930)E K Ind., Inc.1984-09-11
SUPERMOUNT (K842727)E K Ind., Inc.1984-08-03
PRESERV GOMORI TRICHROME STAIN 125/500 (K840087)Preventive Diagnostics Corp.1984-02-10
TRICHROME STAIN LG SOLUTION (K833167)Sigma Chemical Co.1983-10-31
IRON STAIN PROCEDURE HT20 (K833388)Sigma Chemical Co.1983-10-31
LACTO-PHENOL ANILINE BLUE MOUNTING FLUID (K812192)American Scientific Products1981-08-31

Track LED automatically

Every clearance here is in the API, with alerts when new ones post.