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

Container, Specimen, Sterile

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

FMH is the FDA product code for Container, Specimen, Sterile, a class I device type, regulated under 21 CFR 864.3250. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
FMH
Device name
Container, Specimen, 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
23
Ingested recalls
21

Clearances, product code FMH

By decision year
23 clearances under product code FMH with a decision year between 1976 and 1990, 1980 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code FMH by decision year
YearClearances
19761
19774
19784
19794
19806
19811
19821
19831
19901

Applicants with the most clearances

Product code FMH
Applicants holding the most 510(k) clearances under product code FMH
ApplicantClearances
Sage Products LLC4
C.R. Bard Inc2
Sherwood Medical Co.2
Abco Dealers, Inc.1
American Pharmaseal Div. Ahsc1
Chesire Laboratories1
Cordis US Corp.1
General Clinical Plastics Corp.1
Landmark Plastics1
Meridian Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 273 companies shown, in name order