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

Radioimmunoassay, Prolactin (Lactogen)

21 CFR 862.1625 / Clinical Chemistry
FDA source (opens on fda.gov)

CFT is the FDA product code for Radioimmunoassay, Prolactin (Lactogen), a class I device type, regulated under 21 CFR 862.1625. As of , FDA records hold 80 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
CFT
Device name
Radioimmunoassay, Prolactin (Lactogen)
Regulation
21 CFR 862.1625
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
80
Ingested recalls
6

Clearances, product code CFT

By decision year
80 clearances under product code CFT with a decision year between 1979 and 1997, 1986 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code CFT by decision year
YearClearances
19792
19803
19813
19826
19832
19844
19852
198610
19875
19887
19894
19908
19912
19925
19933
19944
19954
19962
19974

Applicants with the most clearances

Product code CFT
Applicants holding the most 510(k) clearances under product code CFT
ApplicantClearances
Siemens Healthcare Diagnostics Inc.6
Abbott Medical5
Hybritech, Inc.4
Amersham Corp.3
BD Becton Dickinson Vacutainer Systems Preanalytic3
Leeco Diagnostics, Inc.3
Medix Biotech, Inc.3
Abbott Mfg., Inc.2
Bio-Rad Laboratories Inc.2
Boehringer Mannheim Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order