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
CFGClass I

Oil Emulsion/Thymolphthalein (Titrimetric), Lipase

21 CFR 862.1465 / Clinical Chemistry
FDA source (opens on fda.gov)

CFG is the FDA product code for Oil Emulsion/Thymolphthalein (Titrimetric), Lipase, a class I device type, regulated under 21 CFR 862.1465. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CFG
Device name
Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Regulation
21 CFR 862.1465
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
2
Ingested recalls
0

Clearances, product code CFG

By decision year
2 clearances under product code CFG with a decision year between 1980 and 1986, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CFG by decision year
YearClearances
19801
19861

Applicants with the most clearances

Product code CFG
Applicants holding the most 510(k) clearances under product code CFG
ApplicantClearances
Sterling Diagnostics, Inc.1
The Dow Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code