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

Radioimmunoassay, Human Placental Lactogen

21 CFR 862.1585 / Clinical Chemistry
FDA source (opens on fda.gov)

JMF is the FDA product code for Radioimmunoassay, Human Placental Lactogen, a class II device type, regulated under 21 CFR 862.1585. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JMF
Device name
Radioimmunoassay, Human Placental Lactogen
Regulation
21 CFR 862.1585
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
11
Ingested recalls
0

Clearances, product code JMF

By decision year
11 clearances under product code JMF with a decision year between 1977 and 1995, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JMF by decision year
YearClearances
19772
19793
19801
19811
19822
19841
19951

Applicants with the most clearances

Product code JMF
Applicants holding the most 510(k) clearances under product code JMF
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Abbott Medical1
Amersham Corp.1
Armkel, LLC1
Corning Medical & Scientific1
Miles Laboratories, Inc.1
Nordiclab Intl.1
Syn-Kit, Inc.1
Technia Diagnostics, Ltd.1
Union Carbide Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code