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

Acid Phosphatase (Prostatic), Tartrate Inhibited

21 CFR 862.1020 / Clinical Chemistry
FDA source (opens on fda.gov)

JFH is the FDA product code for Acid Phosphatase (Prostatic), Tartrate Inhibited, a class II device type, regulated under 21 CFR 862.1020. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JFH
Device name
Acid Phosphatase (Prostatic), Tartrate Inhibited
Regulation
21 CFR 862.1020
Device class
Class II
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
45
Ingested recalls
1

Clearances, product code JFH

By decision year
45 clearances under product code JFH with a decision year between 1979 and 2000, 1979 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code JFH by decision year
YearClearances
19799
19803
19819
19823
19832
19841
19854
19861
19872
19893
19902
19921
19931
19941
19971
19981
20001

Applicants with the most clearances

Product code JFH
Applicants holding the most 510(k) clearances under product code JFH
ApplicantClearances
Siemens Healthcare Diagnostics Inc.6
Hybritech, Inc.4
Abbott Medical3
Biogenex Laboratories, Inc.2
Leeco Diagnostics, Inc.2
Amersham Corp.1
Baxter Healthcare Corporation1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Beckman Instruments, Inc.1
Calbiochem-Behring Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code