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
DOPClass I

Mass Spectrometer, Clinical Use

21 CFR 862.2860 / Clinical Chemistry
FDA source (opens on fda.gov)

DOP is the FDA product code for Mass Spectrometer, Clinical Use, a class I device type, regulated under 21 CFR 862.2860. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
DOP
Device name
Mass Spectrometer, Clinical Use
Regulation
21 CFR 862.2860
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
16

Clearances, product code DOP

By decision year
10 clearances under product code DOP with a decision year between 1977 and 1999, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DOP by decision year
YearClearances
19772
19811
19851
19871
19883
19971
19991

Applicants with the most clearances

Product code DOP
Applicants holding the most 510(k) clearances under product code DOP
ApplicantClearances
Finnigan Corp.3
Revvity Health Sciences, Inc.2
Airspec, Ltd.1
Allied Medical LLC1
Europa Scientific, Ltd.1
Instrumentation Laboratory Co.1
Pdz-Europa, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order